Hemostasis, General Surgery
Conditions
Keywords
Body fluid leakage, Liver, Parenchymal bleeding, Hepatic surgery, Fibrin sealant, Fibrin patch, Human Fibrinogen, Human Thrombin, Coagulation
Brief summary
The Study investigates a new product, sFilm-FS, aimed to help controlling body fluid leakage in general surgery procedures, proposing its use as an adjunct to hemostasis and/or sealing.
Detailed description
Many products have been developed as adjuncts to hemostasis in bleeding situations where traditional methods such as suture, clips or energy-based coagulation are ineffective or impractical. Many products are not as effective in the presence of active and/or brisk bleeding since the lack of sufficient adhesion strength allows forceful bleeding to simply float the products away from the bleeding tissue, prior to the achievement of full hemostasis. The Study investigates a new product, sFilm-FS, aimed to help the control of body fluid leakage in general surgery procedures, proposing its use as an adjunct to hemostasis and/or sealing.
Interventions
COMBINATION_PRODUCTsFilm-FS
sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
COMBINATION_PRODUCTTACHOSIL®
TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
Sponsors
Sintesi Research Srl
Home Medics Consulting Ltd.
Sealantium Medical Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients (males or females) aged ≥ 18 years old. 2. Patients requiring elective open hepatic surgery. 3. Hemoglobin ≥ 8.0 g/dL within 24 hours prior to surgical procedure. 4. Patients understanding the nature of the study and providing their informed consent prior to participation. 5. Patients willing to participate in the study and able to attend the visits and procedures foreseen by study protocol. Intra-operative inclusion criteria: 6. Patients with a target bleeding site (TBS) identified by the Investigator during hepatic surgery (intra-operative inclusion criteria).
Exclusion criteria
1. Patients having undergone a therapeutic surgical procedure within 30 days from the study enrolment. 2. Patients with a severe coagulopathy defined as INR \> 2.0. 3. Patients with platelet count \<50,000 x109 PLT/L at the screening. 4. Patients admitted to trauma surgery. 5. Transplant patients due to fulminant hepatic failure. 6. Patients with known or suspected allergy or hypersensitivity to blood products or to one of the components of sFilm-FS or the active-comparator. 7. Patients with anesthesia risk judged to be higher than ASA3 by the Investigator. 8. Patients with at least one of the following concomitant conditions: severe co-morbid conditions known to pose a high risk for surgery and adequate recovery (i.e., liver cirrhosis with Child-Pugh score B or C, cholestasis, heart diseases), immunodeficiency diseases, blood clotting disorders, any conditions known to effect wound healing (i.e., collagen vascular disease), known or current alcohol or drug abusers. 9. Patients suffering from claustrophobia. 10. Patients with implanted or embedded metal objects, prostheses, pacemaker, or fragments in the head or body that would present a risk during the MRI scanning procedure or have worked with ferrous metals either as a vocation or hobby or following trauma (i.e., sheet metal workers, welders, or machinists) in such a way that might have led to unknown, indwelling metal fragments that could cause injury if they moved in response to placement in the magnetic field. 11. Patients being treated with at least one of the following treatments: antibiotic therapy for active infection, fibrin sealants, systemic steroids, or immunosuppressive agents. 12. Patients who are participating or have participated in other clinical studies within the 30 days before the study enrolment. 13. Female patients who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical study and for three months later. 14. Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception. Intra-operative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Detection of Antibodies Against Fibrinogen. | Last Follow-Up Visit (Visit 9) | Safety will be assessed from randomization of patients until the last follow-up visit by Measuring plasma levels of antibodies against human fibrinogen, by performing a screening assay using bridging ELISA based on polyclonal antibodies against human fibrinogen, which was developed with a sensitivity of 1000 ng/ml. Patients whose results were above 1000ng/ml control were considered positive. |
| To Evaluate the Safety of sFilm-FS Versus an Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Surgery Through ... | From visit 1 to visit 9 (an average of 6.5 months) | Incidence of Treatment-Emergent Adverse Events AEs related to bleeding at TBS, thrombotic events, transfusion-related complications, post-operative adhesions (MRI assessment) |
| To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | From visit 1 to visit 9 (an average of 6.5 months) | Safety will be assessed from randomization of patients until the last follow-up visit by measuring Systolic Blood Pressure (mmHg) |
| To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through Physical Examinations | From visit 1 to visit 9 (an average of 6.5 months) | Safety will be assessed from randomization of patients until the last follow-up visit by physical examination: the detection of the number of patients with at least one clinical abnormality in different body areas (abdomen, eyes, skin, cardiovascular) |
| To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | From visit 1 to visit 9 (an average of 6.5 months) | Safety will be assessed from randomization of patients until the last follow-up visit by urine analysis (pH) |
| To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | From visit 1 to visit 9 (an average of 6.5 months) | Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Hemoglobin (g/L)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Incidence of Re-treatment at the TBS | Day of surgery | Incidence of re-treatment (one or more additional patch of sFilm-FS or TACHOSIL®) at the TBS at the different time points (2 for sFilm-FS, 3, 5, 7, 10 minutes from first product application) |
| To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Percentage of Total Patients That Have Achieved Hemostasis | Day of surgery | Percentage of total patients (patients that achieved hemostasis with a single patch application and patients that required additional patches) that have achieved hemostasis 10 minutes after first product application and therefore did not need to convert to standard of care treatment at the end of these 10 minutes |
| To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through Incidence of Treatment Failure | Day of surgery | Incidence of treatment failure, based on pre-defined treatment failure criteria (in case the bleeding at TBS (or re-bleeding) is still observed after 10 minutes following first application of study product; if hemostasis at TBS is achieved, but the Investigator decides that an additional treatment is required to ensure the durability of hemostasis; if there is a breakthrough bleeding requiring treatment other than the study product, at any time) |
| To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure. | From surgery, up to 6 months | Incidence of transfusion requirements in the 6 months follow-up period |
| To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Proportion of Patients Achieving Hemostasis at TBS | Day of surgery | Proportion of patients achieving hemostasis at TBS (absence of bleeding) at 2 (for sFilm-FS product only), 3, 5, 7 or 10 minutes following first product application, without the occurrence of re-bleeding, starting from 10 minutes after product application and until the completion of surgical closure |
Countries
Austria, Slovenia, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| sFilm-FS sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride. | 17 |
| TACHOSIL® TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin. | 16 |
| Total | 33 |
Baseline characteristics
| Characteristic | sFilm-FS | TACHOSIL® | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 6 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Age, Continuous | 63.47 years STANDARD_DEVIATION 10.46 | 57.81 years STANDARD_DEVIATION 19.28 | 60.73 years STANDARD_DEVIATION 15.39 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 14 Participants | 28 Participants |
| Region of Enrollment Austria | 9 participants | 8 participants | 17 participants |
| Region of Enrollment Slovenia | 5 participants | 5 participants | 10 participants |
| Region of Enrollment United States | 3 participants | 3 participants | 6 participants |
| Sex: Female, Male Female | 8 Participants | 9 Participants | 17 Participants |
| Sex: Female, Male Male | 9 Participants | 7 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 17 | 1 / 16 |
| other Total, other adverse events | 17 / 17 | 16 / 16 |
| serious Total, serious adverse events | 6 / 17 | 5 / 16 |
Outcome results
Primary
To Evaluate the Safety of sFilm-FS Versus an Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Surgery Through ...
Incidence of Treatment-Emergent Adverse Events AEs related to bleeding at TBS, thrombotic events, transfusion-related complications, post-operative adhesions (MRI assessment)
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus an Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Surgery Through ... | Total Number of Treatment-Emergent Adverse Events (TEAE) reported | 179 number of TEAEs |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus an Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Surgery Through ... | Related TEAEs | 0 number of TEAEs |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus an Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Surgery Through ... | TEAEs leading to discontinuation | 1 number of TEAEs |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus an Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Surgery Through ... | Serious TEAEs (SAE) | 8 number of TEAEs |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus an Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Surgery Through ... | Non-fatal serious TEAEs | 7 number of TEAEs |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus an Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Surgery Through ... | TEAEs leading to death | 1 number of TEAEs |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus an Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Surgery Through ... | Non-fatal serious TEAEs | 5 number of TEAEs |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus an Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Surgery Through ... | Total Number of Treatment-Emergent Adverse Events (TEAE) reported | 168 number of TEAEs |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus an Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Surgery Through ... | Serious TEAEs (SAE) | 6 number of TEAEs |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus an Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Surgery Through ... | Related TEAEs | 0 number of TEAEs |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus an Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Surgery Through ... | TEAEs leading to death | 1 number of TEAEs |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus an Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Surgery Through ... | TEAEs leading to discontinuation | 1 number of TEAEs |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through Physical Examinations
Safety will be assessed from randomization of patients until the last follow-up visit by physical examination: the detection of the number of patients with at least one clinical abnormality in different body areas (abdomen, eyes, skin, cardiovascular)
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through Physical Examinations | Visit 1 (Screening) from D-21 to D-1 | 6 number of patients with ≥ 1 abnormality |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through Physical Examinations | Visit 5 (Hospital Discharge) | 3 number of patients with ≥ 1 abnormality |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through Physical Examinations | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 6 number of patients with ≥ 1 abnormality |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through Physical Examinations | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 4 number of patients with ≥ 1 abnormality |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through Physical Examinations | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 6 number of patients with ≥ 1 abnormality |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through Physical Examinations | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 6 number of patients with ≥ 1 abnormality |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through Physical Examinations | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 5 number of patients with ≥ 1 abnormality |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through Physical Examinations | Visit 1 (Screening) from D-21 to D-1 | 7 number of patients with ≥ 1 abnormality |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through Physical Examinations | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 5 number of patients with ≥ 1 abnormality |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through Physical Examinations | Visit 5 (Hospital Discharge) | 5 number of patients with ≥ 1 abnormality |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through Physical Examinations | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 4 number of patients with ≥ 1 abnormality |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through Physical Examinations | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 5 number of patients with ≥ 1 abnormality |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Sodium (mmol/L))
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 140.0 mmol/L | Standard Deviation 3.59 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 140.9 mmol/L | Standard Deviation 2 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 139.1 mmol/L | Standard Deviation 3.19 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 141.5 mmol/L | Standard Deviation 2.54 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 140.9 mmol/L | Standard Deviation 2.72 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 140.8 mmol/L | Standard Deviation 2.1 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 139.4 mmol/L | Standard Deviation 3.38 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 140.3 mmol/L | Standard Deviation 1.62 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 141.1 mmol/L | Standard Deviation 2.26 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 140.6 mmol/L | Standard Deviation 2.79 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 139.9 mmol/L | Standard Deviation 1.89 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 139.0 mmol/L | Standard Deviation 3.89 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 139.8 mmol/L | Standard Deviation 2.63 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 139.7 mmol/L | Standard Deviation 2.85 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 140.6 mmol/L | Standard Deviation 3.07 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 139.1 mmol/L | Standard Deviation 2.41 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 139.9 mmol/L | Standard Deviation 2.41 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 140.5 mmol/L | Standard Deviation 2.78 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (C-Reactive Protein (mg/dL))
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 1.2 mg/dL | Standard Deviation 1.46 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 2.6 mg/dL | Standard Deviation 4.97 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 8.2 mg/dL | Standard Deviation 8.91 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 0.8 mg/dL | Standard Deviation 1.31 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 0.7 mg/dL | Standard Deviation 0.9 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 0.5 mg/dL | Standard Deviation 0.47 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 5.6 mg/dL | Standard Deviation 5.35 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 0.6 mg/dL | Standard Deviation 0.86 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 1.1 mg/dL | Standard Deviation 1.11 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 0.5 mg/dL | Standard Deviation 0.35 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 1.3 mg/dL | Standard Deviation 2.3 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 0.9 mg/dL | Standard Deviation 0.66 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 0.7 mg/dL | Standard Deviation 0.48 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 11.4 mg/dL | Standard Deviation 10.02 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 5.5 mg/dL | Standard Deviation 6.64 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 1.6 mg/dL | Standard Deviation 2.02 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 1.0 mg/dL | Standard Deviation 1.17 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 0.4 mg/dL | Standard Deviation 0.14 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Blood Urea Nitrogen (mmol/L))
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 5.3 mmol/L | Standard Deviation 1.58 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 5.1 mmol/L | Standard Deviation 2.08 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 5.1 mmol/L | Standard Deviation 1.34 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 5.7 mmol/L | Standard Deviation 1.53 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 5.2 mmol/L | Standard Deviation 3.98 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 5.5 mmol/L | Standard Deviation 1.32 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 5.8 mmol/L | Standard Deviation 1.09 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 4.2 mmol/L | Standard Deviation 1.42 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 4.7 mmol/L | Standard Deviation 2.14 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 4.2 mmol/L | Standard Deviation 2.31 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 5.2 mmol/L | Standard Deviation 1.28 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 4.6 mmol/L | Standard Deviation 2.03 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 4.9 mmol/L | Standard Deviation 2.49 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 4.3 mmol/L | Standard Deviation 1.73 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 4.6 mmol/L | Standard Deviation 1.65 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 4.1 mmol/L | Standard Deviation 1.38 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 4.7 mmol/L | Standard Deviation 1.55 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 4.7 mmol/L | Standard Deviation 1.98 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Creatinine (micromol/L))
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 82.1 micromol/L | Standard Deviation 21.02 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 69.0 micromol/L | Standard Deviation 16.5 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 67.6 micromol/L | Standard Deviation 34.13 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 71.7 micromol/L | Standard Deviation 16.01 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 71.9 micromol/L | Standard Deviation 18.48 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 73.4 micromol/L | Standard Deviation 21.88 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 66.7 micromol/L | Standard Deviation 19.76 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 72.4 micromol/L | Standard Deviation 17.81 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 73.6 micromol/L | Standard Deviation 18.12 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 61.6 micromol/L | Standard Deviation 9.91 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 61.7 micromol/L | Standard Deviation 11.56 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 68.9 micromol/L | Standard Deviation 10.62 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 66.5 micromol/L | Standard Deviation 19.42 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 58.7 micromol/L | Standard Deviation 19.73 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 59.8 micromol/L | Standard Deviation 14.82 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 60.0 micromol/L | Standard Deviation 7.58 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 62.7 micromol/L | Standard Deviation 13.46 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 65.9 micromol/L | Standard Deviation 15.73 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Uric Acid (micromol/L))
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 320.4 micromol/L | Standard Deviation 84.22 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 358.1 micromol/L | Standard Deviation 307.01 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 505.9 micromol/L | Standard Deviation 550.82 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 317.9 micromol/L | Standard Deviation 87.8 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 534.2 micromol/L | Standard Deviation 585.91 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 321.4 micromol/L | Standard Deviation 90.98 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 426.7 micromol/L | Standard Deviation 423.5 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 401.6 micromol/L | Standard Deviation 345.94 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 434.0 micromol/L | Standard Deviation 324.04 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 312.4 micromol/L | Standard Deviation 111.15 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 376.1 micromol/L | Standard Deviation 306.72 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 346.5 micromol/L | Standard Deviation 102.24 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 401.1 micromol/L | Standard Deviation 296.09 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 304.8 micromol/L | Standard Deviation 153.16 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 343.7 micromol/L | Standard Deviation 210.83 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 431.3 micromol/L | Standard Deviation 435.82 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 340.0 micromol/L | Standard Deviation 59.81 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 338.1 micromol/L | Standard Deviation 124.09 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Total Bilirubin (micromol/L))
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 10.8 micromol/L | Standard Deviation 7.62 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 9.4 micromol/L | Standard Deviation 5.11 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 16.9 micromol/L | Standard Deviation 19.88 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 8.7 micromol/L | Standard Deviation 5.89 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 18.5 micromol/L | Standard Deviation 15.69 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 10.1 micromol/L | Standard Deviation 5.55 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 9.8 micromol/L | Standard Deviation 6.61 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 11.0 micromol/L | Standard Deviation 7.6 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 10.9 micromol/L | Standard Deviation 6.71 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 11.3 micromol/L | Standard Deviation 6.1 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 12.0 micromol/L | Standard Deviation 6.93 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 11.6 micromol/L | Standard Deviation 4.63 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 11.6 micromol/L | Standard Deviation 6.25 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 13.1 micromol/L | Standard Deviation 12.01 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 8.0 micromol/L | Standard Deviation 4.57 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 7.1 micromol/L | Standard Deviation 2.51 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 6.7 micromol/L | Standard Deviation 2.15 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 7.9 micromol/L | Standard Deviation 5.51 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Lactate Dehydrogenase (microkat/L))
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 3.6 microkat/L | Standard Deviation 0.5 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 3.5 microkat/L | Standard Deviation 0.64 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 4.8 microkat/L | Standard Deviation 2.3 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 3.6 microkat/L | Standard Deviation 0.44 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 8.1 microkat/L | Standard Deviation 6.18 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 3.3 microkat/L | Standard Deviation 1.63 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 4.0 microkat/L | Standard Deviation 0.92 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 2.9 microkat/L | Standard Deviation 0.83 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 3.7 microkat/L | Standard Deviation 0.68 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 3.1 microkat/L | Standard Deviation 1.08 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 3.9 microkat/L | Standard Deviation 2.28 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 3.4 microkat/L | Standard Deviation 0.75 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 5.5 microkat/L | Standard Deviation 2.72 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 4.6 microkat/L | Standard Deviation 1.29 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 4.5 microkat/L | Standard Deviation 1.19 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 3.6 microkat/L | Standard Deviation 0.9 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 3.7 microkat/L | Standard Deviation 1.01 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 3.0 microkat/L | Standard Deviation 1.6 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Serum Glutamic Oxaloacetic Transaminase/Aspartate Aminotransferase (microkat/L))
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 0.5 microkat/L | Standard Deviation 0.21 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 0.5 microkat/L | Standard Deviation 0.22 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 2.3 microkat/L | Standard Deviation 3.42 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 0.5 microkat/L | Standard Deviation 0.3 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 4.2 microkat/L | Standard Deviation 4.42 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 0.5 microkat/L | Standard Deviation 0.31 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 0.7 microkat/L | Standard Deviation 0.34 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 0.5 microkat/L | Standard Deviation 0.21 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 0.6 microkat/L | Standard Deviation 0.29 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 0.5 microkat/L | Standard Deviation 0.21 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 0.4 microkat/L | Standard Deviation 0.23 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 0.4 microkat/L | Standard Deviation 0.11 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 1.8 microkat/L | Standard Deviation 1.58 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 1.2 microkat/L | Standard Deviation 1.07 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 0.9 microkat/L | Standard Deviation 0.62 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 0.4 microkat/L | Standard Deviation 0.14 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 0.5 microkat/L | Standard Deviation 0.16 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 0.4 microkat/L | Standard Deviation 0.24 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Serum Glutamic Pyruvic Transaminase/Alanine Aminotransferase (microkat/L))
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 0.4 microkat/L | Standard Deviation 0.22 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 0.7 microkat/L | Standard Deviation 1.09 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 2.9 microkat/L | Standard Deviation 3.86 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 0.5 microkat/L | Standard Deviation 0.41 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 3.2 microkat/L | Standard Deviation 3.53 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 0.5 microkat/L | Standard Deviation 0.31 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 0.8 microkat/L | Standard Deviation 0.58 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 0.5 microkat/L | Standard Deviation 0.3 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 0.6 microkat/L | Standard Deviation 0.47 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 0.4 microkat/L | Standard Deviation 0.2 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 0.4 microkat/L | Standard Deviation 0.23 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 0.5 microkat/L | Standard Deviation 0.17 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 1.4 microkat/L | Standard Deviation 1.34 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 1.4 microkat/L | Standard Deviation 1.53 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 1.4 microkat/L | Standard Deviation 1.28 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 0.4 microkat/L | Standard Deviation 0.23 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 0.4 microkat/L | Standard Deviation 0.23 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 0.4 microkat/L | Standard Deviation 0.14 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Gamma-GT (microkat/L))
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 0.6 microkat/L | Standard Deviation 0.33 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 3.8 microkat/L | Standard Deviation 7.12 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 4.7 microkat/L | Standard Deviation 7.43 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 0.8 microkat/L | Standard Deviation 0.82 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 2.8 microkat/L | Standard Deviation 7.85 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 0.8 microkat/L | Standard Deviation 0.95 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 3.0 microkat/L | Standard Deviation 6.16 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 1.2 microkat/L | Standard Deviation 1.18 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 2.9 microkat/L | Standard Deviation 7.82 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 0.9 microkat/L | Standard Deviation 1.01 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 1.1 microkat/L | Standard Deviation 1.1 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 0.8 microkat/L | Standard Deviation 1.2 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 0.7 microkat/L | Standard Deviation 0.89 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 1.1 microkat/L | Standard Deviation 0.91 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 1.7 microkat/L | Standard Deviation 1.23 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 1.3 microkat/L | Standard Deviation 0.96 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 0.8 microkat/L | Standard Deviation 0.91 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 0.8 microkat/L | Standard Deviation 0.85 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Calcium (mmol/L))
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 2.4 mmol/L | Standard Deviation 0.11 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 2.5 mmol/L | Standard Deviation 0.45 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 2.1 mmol/L | Standard Deviation 0.14 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 2.4 mmol/L | Standard Deviation 0.11 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 2.1 mmol/L | Standard Deviation 0.11 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 2.4 mmol/L | Standard Deviation 0.16 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 2.2 mmol/L | Standard Deviation 0.16 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 2.4 mmol/L | Standard Deviation 0.16 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 2.4 mmol/L | Standard Deviation 0.1 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 2.4 mmol/L | Standard Deviation 0.09 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 2.3 mmol/L | Standard Deviation 0.16 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 2.3 mmol/L | Standard Deviation 0.12 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 2.1 mmol/L | Standard Deviation 0.11 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 2.1 mmol/L | Standard Deviation 0.12 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 2.2 mmol/L | Standard Deviation 0.13 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 3.0 mmol/L | Standard Deviation 1.93 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 2.4 mmol/L | Standard Deviation 0.05 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 2.4 mmol/L | Standard Deviation 0.1 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Phosphorous (mmol/L))
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 1.2 mmol/L | Standard Deviation 0.08 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 1.1 mmol/L | Standard Deviation 0.11 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 0.9 mmol/L | Standard Deviation 0.32 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 1.1 mmol/L | Standard Deviation 0.28 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 1.2 mmol/L | Standard Deviation 0.2 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 1.0 mmol/L | Standard Deviation 0.24 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 1.0 mmol/L | Standard Deviation 0.19 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 1.2 mmol/L | Standard Deviation 0.2 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 1.0 mmol/L | Standard Deviation 0.12 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 8.7 mmol/L | Standard Deviation 28.57 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 1.1 mmol/L | Standard Deviation 0.21 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 1.1 mmol/L | Standard Deviation 0.16 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 1.1 mmol/L | Standard Deviation 0.33 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 0.9 mmol/L | Standard Deviation 0.24 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 1.0 mmol/L | Standard Deviation 0.3 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 1.1 mmol/L | Standard Deviation 0.19 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 1.1 mmol/L | Standard Deviation 0.17 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 1.1 mmol/L | Standard Deviation 0.15 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Glucose (mmol/L))
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 6.7 mmol/L | Standard Deviation 3.15 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 6.2 mmol/L | Standard Deviation 1.52 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 6.1 mmol/L | Standard Deviation 1.91 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 5.9 mmol/L | Standard Deviation 1.59 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 8.1 mmol/L | Standard Deviation 2.5 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 5.2 mmol/L | Standard Deviation 1.73 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 6.4 mmol/L | Standard Deviation 1.62 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 6.0 mmol/L | Standard Deviation 1.83 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 6.5 mmol/L | Standard Deviation 2.51 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 5.7 mmol/L | Standard Deviation 3.37 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 5.6 mmol/L | Standard Deviation 1.27 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 6.4 mmol/L | Standard Deviation 3.78 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 7.6 mmol/L | Standard Deviation 2.65 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 6.5 mmol/L | Standard Deviation 2.23 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 6.0 mmol/L | Standard Deviation 1.5 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 5.9 mmol/L | Standard Deviation 1.91 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 6.9 mmol/L | Standard Deviation 3.83 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 7.1 mmol/L | Standard Deviation 5.5 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Albumin (g/L))
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 42.6 g/L | Standard Deviation 3.89 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 40.0 g/L | Standard Deviation 3.35 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 28.6 g/L | Standard Deviation 4.71 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 41.7 g/L | Standard Deviation 2.95 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 32.8 g/L | Standard Deviation 4.77 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 42.9 g/L | Standard Deviation 4.38 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 32.4 g/L | Standard Deviation 5.25 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 43.2 g/L | Standard Deviation 4.71 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 42.4 g/L | Standard Deviation 4.16 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 43.8 g/L | Standard Deviation 4.92 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 42.5 g/L | Standard Deviation 5.67 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 44.0 g/L | Standard Deviation 4.99 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 34.5 g/L | Standard Deviation 4.95 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 30.7 g/L | Standard Deviation 5.08 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 34.0 g/L | Standard Deviation 6.81 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 41.1 g/L | Standard Deviation 4.85 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 41.9 g/L | Standard Deviation 3.93 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 44.6 g/L | Standard Deviation 5.01 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Total Protein (g/L))
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 71.1 g/L | Standard Deviation 5.41 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 75.0 g/L | Standard Deviation 6.53 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 54.9 g/L | Standard Deviation 8.68 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 72.4 g/L | Standard Deviation 4.99 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 56.6 g/L | Standard Deviation 8.07 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 75.1 g/L | Standard Deviation 6.15 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 63.2 g/L | Standard Deviation 9.92 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 74.8 g/L | Standard Deviation 6.21 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 73.2 g/L | Standard Deviation 5.93 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 75.3 g/L | Standard Deviation 5.42 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 73.0 g/L | Standard Deviation 9.29 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 74.9 g/L | Standard Deviation 8.89 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 62.0 g/L | Standard Deviation 8.83 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 60.5 g/L | Standard Deviation 10.16 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 64.5 g/L | Standard Deviation 9.6 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 76.1 g/L | Standard Deviation 9.44 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 79.3 g/L | Standard Deviation 8.28 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 77.7 g/L | Standard Deviation 8.1 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Hemoglobin (g/L))
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 118.8 g/L | Standard Deviation 14.03 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 136.1 g/L | Standard Deviation 20.54 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 138.0 g/L | Standard Deviation 15.13 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 118.8 g/L | Standard Deviation 10.64 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 104.5 g/L | Standard Deviation 17.14 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 106.8 g/L | Standard Deviation 16.19 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 117.3 g/L | Standard Deviation 17.02 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 126.8 g/L | Standard Deviation 12.66 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 129.7 g/L | Standard Deviation 11.66 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 136.3 g/L | Standard Deviation 18.77 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 111.7 g/L | Standard Deviation 19.8 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 135.6 g/L | Standard Deviation 14 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 128.9 g/L | Standard Deviation 18.64 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 135.0 g/L | Standard Deviation 15.6 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 122.1 g/L | Standard Deviation 15.45 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 121.9 g/L | Standard Deviation 12.74 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 119.3 g/L | Standard Deviation 14.66 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 108.4 g/L | Standard Deviation 15.96 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Mean Cell Hemoglobin Concentration (g/L))
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 335.5 g/L | Standard Deviation 8.14 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 322.6 g/L | Standard Deviation 12.02 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 336.6 g/L | Standard Deviation 10.82 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 324.9 g/L | Standard Deviation 11.02 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 338.3 g/L | Standard Deviation 12.16 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 329.8 g/L | Standard Deviation 11.91 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 335.9 g/L | Standard Deviation 10.53 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 329.9 g/L | Standard Deviation 10.77 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 337.3 g/L | Standard Deviation 15.4 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 334.9 g/L | Standard Deviation 15.16 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 337.5 g/L | Standard Deviation 11.83 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 337.5 g/L | Standard Deviation 8.4 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 337.7 g/L | Standard Deviation 12.56 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 333.8 g/L | Standard Deviation 11.41 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 333.6 g/L | Standard Deviation 12.87 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 332.1 g/L | Standard Deviation 12.48 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 326.7 g/L | Standard Deviation 16.71 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 326.6 g/L | Standard Deviation 8.88 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Mean Cell Hemoglobin (pg))
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 31.3 pg | Standard Deviation 2.01 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 28.7 pg | Standard Deviation 2.26 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 30.1 pg | Standard Deviation 2.11 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 28.7 pg | Standard Deviation 2.38 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 30.4 pg | Standard Deviation 1.95 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 28.8 pg | Standard Deviation 3.26 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 30.1 pg | Standard Deviation 1.81 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 29.4 pg | Standard Deviation 2.53 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 29.8 pg | Standard Deviation 3 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 29.6 pg | Standard Deviation 3.27 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 29.5 pg | Standard Deviation 2.27 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 28.2 pg | Standard Deviation 2.22 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 29.3 pg | Standard Deviation 2.17 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 29.6 pg | Standard Deviation 2.05 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 29.3 pg | Standard Deviation 2.45 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 29.1 pg | Standard Deviation 2.89 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 27.5 pg | Standard Deviation 3 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 27.1 pg | Standard Deviation 3.1 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Mean Corpuscular Volume (fL))
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 93.1 fL | Standard Deviation 4.7 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 88.9 fL | Standard Deviation 5.43 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 89.5 fL | Standard Deviation 5.62 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 88.5 fL | Standard Deviation 6.51 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 90.4 fL | Standard Deviation 5.84 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 86.9 fL | Standard Deviation 7.83 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 89.9 fL | Standard Deviation 4.51 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 88.2 fL | Standard Deviation 6.96 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 88.5 fL | Standard Deviation 6.83 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 88.8 fL | Standard Deviation 9.02 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 87.8 fL | Standard Deviation 7.34 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 84.3 fL | Standard Deviation 8.21 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 86.8 fL | Standard Deviation 6.91 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 88.9 fL | Standard Deviation 6.35 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 87.6 fL | Standard Deviation 7.31 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 87.9 fL | Standard Deviation 8.29 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 84.3 fL | Standard Deviation 8.79 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 82.9 fL | Standard Deviation 8.3 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Red Blood Cell (10\^12cells/L))
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 4.4 10^12cells/L | Standard Deviation 0.4 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 4.1 10^12cells/L | Standard Deviation 0.58 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 3.5 10^12cells/L | Standard Deviation 0.58 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 4.1 10^12cells/L | Standard Deviation 0.43 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 4.6 10^12cells/L | Standard Deviation 0.57 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 4.4 10^12cells/L | Standard Deviation 0.34 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 3.6 10^12cells/L | Standard Deviation 0.61 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 4.5 10^12cells/L | Standard Deviation 0.31 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 3.9 10^12cells/L | Standard Deviation 0.41 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 4.6 10^12cells/L | Standard Deviation 0.71 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 4.6 10^12cells/L | Standard Deviation 0.53 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 4.8 10^12cells/L | Standard Deviation 0.57 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 4.2 10^12cells/L | Standard Deviation 0.57 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 3.7 10^12cells/L | Standard Deviation 0.63 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 3.8 10^12cells/L | Standard Deviation 0.66 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 4.2 10^12cells/L | Standard Deviation 0.52 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 4.4 10^12cells/L | Standard Deviation 0.52 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 4.8 10^12cells/L | Standard Deviation 0.63 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (White Blood Cell (10\^9cells/L))
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 8.1 10^9cells/L | Standard Deviation 2 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 6.8 10^9cells/L | Standard Deviation 2.33 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 6.43 10^9cells/L | Standard Deviation 4.61 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 6.2 10^9cells/L | Standard Deviation 3.2 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 11.9 10^9cells/L | Standard Deviation 3.81 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 6.3 10^9cells/L | Standard Deviation 2.56 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 8.2 10^9cells/L | Standard Deviation 2.93 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 8.4 10^9cells/L | Standard Deviation 4.42 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 7.2 10^9cells/L | Standard Deviation 2.47 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 7.8 10^9cells/L | Standard Deviation 1.53 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 8.0 10^9cells/L | Standard Deviation 2.58 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 9.2 10^9cells/L | Standard Deviation 3.21 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 10.9 10^9cells/L | Standard Deviation 6.43 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 12.1 10^9cells/L | Standard Deviation 6.26 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 9.6 10^9cells/L | Standard Deviation 5.23 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 8.1 10^9cells/L | Standard Deviation 2.01 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 7.4 10^9cells/L | Standard Deviation 2.47 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 8.0 10^9cells/L | Standard Deviation 2.24 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Platelet (10\^9cells/L))
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 241.6 10^9cells/L | Standard Deviation 82.68 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 260.9 10^9cells/L | Standard Deviation 111.99 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 238.4 10^9cells/L | Standard Deviation 104.66 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 216.8 10^9cells/L | Standard Deviation 114.38 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 227.4 10^9cells/L | Standard Deviation 100.21 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 203.8 10^9cells/L | Standard Deviation 115.82 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 308.4 10^9cells/L | Standard Deviation 153.07 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 250.2 10^9cells/L | Standard Deviation 98.07 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 241.6 10^9cells/L | Standard Deviation 104.69 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 276.4 10^9cells/L | Standard Deviation 141.69 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 278.7 10^9cells/L | Standard Deviation 90.9 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 308.2 10^9cells/L | Standard Deviation 125.23 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 275.0 10^9cells/L | Standard Deviation 122.16 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 312.6 10^9cells/L | Standard Deviation 173.32 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 403.5 10^9cells/L | Standard Deviation 272.79 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 330.1 10^9cells/L | Standard Deviation 189.33 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 397.3 10^9cells/L | Standard Deviation 204.51 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 342.9 10^9cells/L | Standard Deviation 169.86 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Fibrinogen (g/L))
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 3.8 g/L | Standard Deviation 0.87 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 4.7 g/L | Standard Deviation 1.68 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 4.9 g/L | Standard Deviation 1.21 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 3.7 g/L | Standard Deviation 0.75 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 3.0 g/L | Standard Deviation 0.81 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 3.6 g/L | Standard Deviation 0.95 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 5.2 g/L | Standard Deviation 1.1 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 3.8 g/L | Standard Deviation 0.96 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 4.1 g/L | Standard Deviation 1.16 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 3.2 g/L | Standard Deviation 0.47 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 4.3 g/L | Standard Deviation 1.88 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 4.3 g/L | Standard Deviation 0.82 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 3.5 g/L | Standard Deviation 0.63 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 5.8 g/L | Standard Deviation 2.48 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 5.8 g/L | Standard Deviation 2.46 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 4.4 g/L | Standard Deviation 1.88 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 4.6 g/L | Standard Deviation 2.05 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 3.6 g/L | Standard Deviation 0.71 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (D-Dimer (microg/mL))
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 0.8 microg/mL | Standard Deviation 0.46 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 2.3 microg/mL | Standard Deviation 1.78 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 5.0 microg/mL | Standard Deviation 3.32 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 1.1 microg/mL | Standard Deviation 0.68 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 3.8 microg/mL | Standard Deviation 3.58 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 1.2 microg/mL | Standard Deviation 1.05 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 4.8 microg/mL | Standard Deviation 4.54 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 1.4 microg/mL | Standard Deviation 2.03 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 1.1 microg/mL | Standard Deviation 0.81 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 4.0 microg/mL | Standard Deviation 11.25 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 0.9 microg/mL | Standard Deviation 0.9 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 1.3 microg/mL | Standard Deviation 1.51 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 2.8 microg/mL | Standard Deviation 2.57 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 3.3 microg/mL | Standard Deviation 1.76 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 4.9 microg/mL | Standard Deviation 3.69 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 2.2 microg/mL | Standard Deviation 3.09 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 1.3 microg/mL | Standard Deviation 1.33 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 0.6 microg/mL | Standard Deviation 0.3 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Erythrocyte Sedimentation Rate (mm/hr))
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 20.6 mm/hr | Standard Deviation 14.29 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 39.8 mm/hr | Standard Deviation 28.87 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 48.5 mm/hr | Standard Deviation 25.46 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 16.5 mm/hr | Standard Deviation 10.56 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 17.6 mm/hr | Standard Deviation 12.87 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 18.0 mm/hr | Standard Deviation 14.13 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 55.7 mm/hr | Standard Deviation 31.99 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 17.7 mm/hr | Standard Deviation 13.24 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 18.3 mm/hr | Standard Deviation 11.6 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 18.0 mm/hr | Standard Deviation 9.86 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 1 (Screening) from D-21 to D-1 | 23.7 mm/hr | Standard Deviation 18.44 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 21.9 mm/hr | Standard Deviation 6.85 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 3 (Surgery) D0 | 18.9 mm/hr | Standard Deviation 13.3 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 53.7 mm/hr | Standard Deviation 37.18 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 5 (Hospital Discharge) | 61.9 mm/hr | Standard Deviation 41.07 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 55.1 mm/hr | Standard Deviation 51.17 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 46.9 mm/hr | Standard Deviation 37.53 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 28.1 mm/hr | Standard Deviation 18.64 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values
Safety will be assessed from randomization of patients until the last follow-up visit by urine analysis (pH)
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 1 (Screening) from D-21 to D-1 | 5.5 pH | Standard Deviation 0.6 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 5.7 pH | Standard Deviation 0.59 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 3 (Surgery) D0 | 5.4 pH | Standard Deviation 0.68 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 5 (Hospital Discharge) | 6.2 pH | Standard Deviation 1.01 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 6.3 pH | Standard Deviation 1.01 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 5.7 pH | Standard Deviation 0.78 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 5.8 pH | Standard Deviation 0.81 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 1 (Screening) from D-21 to D-1 | 5.9 pH | Standard Deviation 0.84 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 5 (Hospital Discharge) | 6.7 pH | Standard Deviation 1.09 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 5.9 pH | Standard Deviation 0.88 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 6.0 pH | Standard Deviation 0.9 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 3 (Surgery) D0 | 5.9 pH | Standard Deviation 0.88 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values
Safety will be assessed from randomization of patients until the last follow-up visit by urine analysis (Presence of Glucose)
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 1 (Screening) from D-21 to D-1 | 6 participants |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 1 participants |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 3 (Surgery) D0 | 5 participants |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 5 (Hospital Discharge) | 7 participants |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 5 participants |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 0 participants |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 0 participants |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 2 participants |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 3 participants |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 1 (Screening) from D-21 to D-1 | 4 participants |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 4 participants |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 0 participants |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 0 participants |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 3 (Surgery) D0 | 4 participants |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 0 participants |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 5 (Hospital Discharge) | 4 participants |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values
Safety will be assessed from randomization of patients until the last follow-up visit by urine analysis (Specific Gravity (g/L))
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 1 (Screening) from D-21 to D-1 | 1021.6 g/L | Standard Deviation 9.52 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 1017.2 g/L | Standard Deviation 4.65 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 3 (Surgery) D0 | 1027.2 g/L | Standard Deviation 11.07 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 5 (Hospital Discharge) | 1018.2 g/L | Standard Deviation 8.94 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 1019.9 g/L | Standard Deviation 7.62 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 1017.4 g/L | Standard Deviation 6.02 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 1019.7 g/L | Standard Deviation 8.96 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 1 (Screening) from D-21 to D-1 | 1018.8 g/L | Standard Deviation 7.25 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 5 (Hospital Discharge) | 1024.9 g/L | Standard Deviation 21.39 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 1019.2 g/L | Standard Deviation 8.61 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 1020.1 g/L | Standard Deviation 7.61 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values | Visit 3 (Surgery) D0 | 1022.4 g/L | Standard Deviation 7.59 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Safety will be assessed from randomization of patients until the last follow-up visit by measuring Respiratory Rate (breaths/minute)
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 14.5 breaths/minute | Standard Deviation 2.27 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 13.7 breaths/minute | Standard Deviation 2.32 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 15.0 breaths/minute | Standard Deviation 2.88 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 13.1 breaths/minute | Standard Deviation 1.81 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 1 (Screening) from D-21 to D-1 | 14.5 breaths/minute | Standard Deviation 3.14 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 14.6 breaths/minute | Standard Deviation 2.29 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 5 (Hospital Discharge) | 15.4 breaths/minute | Standard Deviation 3.12 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 13.6 breaths/minute | Standard Deviation 2.36 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 3 (Surgery) D0 | 15.8 breaths/minute | Standard Deviation 7.59 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 14.1 breaths/minute | Standard Deviation 1.44 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 1 (Screening) from D-21 to D-1 | 13.5 breaths/minute | Standard Deviation 1.83 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 15.4 breaths/minute | Standard Deviation 2.56 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 3 (Surgery) D0 | 15.0 breaths/minute | Standard Deviation 3.13 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 16.8 breaths/minute | Standard Deviation 3.76 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 5 (Hospital Discharge) | 22.4 breaths/minute | Standard Deviation 27.55 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 12.9 breaths/minute | Standard Deviation 1 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 14.3 breaths/minute | Standard Deviation 1.8 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 13.4 breaths/minute | Standard Deviation 1.41 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Safety will be assessed from randomization of patients until the last follow-up visit by measuring Body Temperature (°C)
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 36.6 °C | Standard Deviation 0.44 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 36.4 °C | Standard Deviation 0.53 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 36.6 °C | Standard Deviation 0.44 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 36.5 °C | Standard Deviation 0.34 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 3 (Surgery) D0 | 36.4 °C | Standard Deviation 0.77 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 36.3 °C | Standard Deviation 0.59 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 5 (Hospital Discharge) | 36.7 °C | Standard Deviation 0.39 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 36.5 °C | Standard Deviation 0.39 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 1 (Screening) from D-21 to D-1 | 36.5 °C | Standard Deviation 0.39 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 36.3 °C | Standard Deviation 0.3 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 1 (Screening) from D-21 to D-1 | 36.7 °C | Standard Deviation 0.33 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 36.4 °C | Standard Deviation 0.4 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 3 (Surgery) D0 | 36.3 °C | Standard Deviation 0.61 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 36.8 °C | Standard Deviation 0.51 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 5 (Hospital Discharge) | 36.7 °C | Standard Deviation 0.52 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 36.4 °C | Standard Deviation 0.43 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 36.8 °C | Standard Deviation 0.17 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 36.8 °C | Standard Deviation 0.2 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Safety will be assessed from randomization of patients until the last follow-up visit by measuring Systolic Blood Pressure (mmHg)
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 138.9 mmHg | Standard Deviation 11.89 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 131.6 mmHg | Standard Deviation 13.53 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 129.1 mmHg | Standard Deviation 16.97 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 133.5 mmHg | Standard Deviation 12.52 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 3 (Surgery) D0 | 118.9 mmHg | Standard Deviation 20.5 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 130.6 mmHg | Standard Deviation 17.12 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 5 (Hospital Discharge) | 133.1 mmHg | Standard Deviation 20.14 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 127.0 mmHg | Standard Deviation 19.49 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 1 (Screening) from D-21 to D-1 | 137.1 mmHg | Standard Deviation 12.63 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 134.5 mmHg | Standard Deviation 19.07 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 1 (Screening) from D-21 to D-1 | 129.8 mmHg | Standard Deviation 16.75 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 133.0 mmHg | Standard Deviation 11.1 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 3 (Surgery) D0 | 111.4 mmHg | Standard Deviation 14.75 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 131.4 mmHg | Standard Deviation 21.22 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 5 (Hospital Discharge) | 130.7 mmHg | Standard Deviation 21.08 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 123.6 mmHg | Standard Deviation 17.35 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 130.0 mmHg | Standard Deviation 15.46 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 133.4 mmHg | Standard Deviation 10.34 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Safety will be assessed from randomization of patients until the last follow-up visit by measuring Diastolic Blood Pressure (mmHg)
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 75.4 mmHg | Standard Deviation 8.33 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 79.7 mmHg | Standard Deviation 7.9 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 74.2 mmHg | Standard Deviation 12.23 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 80.8 mmHg | Standard Deviation 9.96 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 3 (Surgery) D0 | 61.6 mmHg | Standard Deviation 14.6 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 81.0 mmHg | Standard Deviation 11.86 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 5 (Hospital Discharge) | 74.9 mmHg | Standard Deviation 9.5 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 79.4 mmHg | Standard Deviation 9.58 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 1 (Screening) from D-21 to D-1 | 81.0 mmHg | Standard Deviation 10.59 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 82.3 mmHg | Standard Deviation 11.56 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 1 (Screening) from D-21 to D-1 | 76.0 mmHg | Standard Deviation 7.27 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 81.7 mmHg | Standard Deviation 13.61 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 3 (Surgery) D0 | 62.3 mmHg | Standard Deviation 10.87 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 75.6 mmHg | Standard Deviation 11.52 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 5 (Hospital Discharge) | 79.9 mmHg | Standard Deviation 11.58 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 81.6 mmHg | Standard Deviation 8.45 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 81.4 mmHg | Standard Deviation 6.88 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 82.7 mmHg | Standard Deviation 7.57 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Safety will be assessed from randomization of patients until the last follow-up visit by measuring Heart Rate (beats/minute)
Time frame: From visit 1 to visit 9 (an average of 6.5 months)
Population: Descriptive Analysis on Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 74.5 beats/minute | Standard Deviation 12.39 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 77.3 beats/minute | Standard Deviation 16.62 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 77.1 beats/minute | Standard Deviation 11.17 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 74.2 beats/minute | Standard Deviation 14.26 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 3 (Surgery) D0 | 69.0 beats/minute | Standard Deviation 19.94 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 73.7 beats/minute | Standard Deviation 10.11 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 5 (Hospital Discharge) | 79.1 beats/minute | Standard Deviation 11.56 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 73.7 beats/minute | Standard Deviation 16.23 |
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 1 (Screening) from D-21 to D-1 | 72.2 beats/minute | Standard Deviation 13.44 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3 | 73.7 beats/minute | Standard Deviation 13.78 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 1 (Screening) from D-21 to D-1 | 74.6 beats/minute | Standard Deviation 11.94 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1) | 79.0 beats/minute | Standard Deviation 16.98 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 3 (Surgery) D0 | 79.2 beats/minute | Standard Deviation 13.93 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge | 80.9 beats/minute | Standard Deviation 18.18 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 5 (Hospital Discharge) | 84.2 beats/minute | Standard Deviation 14.87 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3 | 78.1 beats/minute | Standard Deviation 17.17 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3 | 83.1 beats/minute | Standard Deviation 8.45 |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs | Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3 | 74.4 beats/minute | Standard Deviation 7.61 |
Primary
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Detection of Antibodies Against Fibrinogen.
Safety will be assessed from randomization of patients until the last follow-up visit by Measuring plasma levels of antibodies against human fibrinogen, by performing a screening assay using bridging ELISA based on polyclonal antibodies against human fibrinogen, which was developed with a sensitivity of 1000 ng/ml. Patients whose results were above 1000ng/ml control were considered positive.
Time frame: Last Follow-Up Visit (Visit 9)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| sFilm-FS | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Detection of Antibodies Against Fibrinogen. | 2 Participants |
| TACHOSIL® | To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Detection of Antibodies Against Fibrinogen. | 2 Participants |
Secondary
To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure.
Incidence of transfusion requirements in the 6 months follow-up period
Time frame: From surgery, up to 6 months
Population: Descriptive statistics of all randomized patients who underwent surgery, received at least one dose of study treatment and having no major violations of inclusion and exclusion criteria
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| sFilm-FS | To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure. | 1 participants |
| TACHOSIL® | To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure. | 1 participants |
Secondary
To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through Incidence of Treatment Failure
Incidence of treatment failure, based on pre-defined treatment failure criteria (in case the bleeding at TBS (or re-bleeding) is still observed after 10 minutes following first application of study product; if hemostasis at TBS is achieved, but the Investigator decides that an additional treatment is required to ensure the durability of hemostasis; if there is a breakthrough bleeding requiring treatment other than the study product, at any time)
Time frame: Day of surgery
Population: Descriptive statistics of all randomized patients who underwent surgery, received at least one dose of study treatment and having no major violations of inclusion and exclusion criteria
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| sFilm-FS | To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through Incidence of Treatment Failure | 2 Participants |
| TACHOSIL® | To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through Incidence of Treatment Failure | 0 Participants |
Secondary
To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Incidence of Re-treatment at the TBS
Incidence of re-treatment (one or more additional patch of sFilm-FS or TACHOSIL®) at the TBS at the different time points (2 for sFilm-FS, 3, 5, 7, 10 minutes from first product application)
Time frame: Day of surgery
Population: Descriptive statistics of all randomized patients who underwent surgery, received at least one dose of study treatment and having no major violations of inclusion and exclusion criteria
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| sFilm-FS | To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Incidence of Re-treatment at the TBS | 3 minutes after application | 0 Participants |
| sFilm-FS | To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Incidence of Re-treatment at the TBS | 7 minutes after application | 0 Participants |
| sFilm-FS | To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Incidence of Re-treatment at the TBS | 5 minutes after application | 0 Participants |
| sFilm-FS | To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Incidence of Re-treatment at the TBS | 10 minutes after application | 2 Participants |
| sFilm-FS | To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Incidence of Re-treatment at the TBS | 2 minutes after application (only for sFilm-FS) | 0 Participants |
| TACHOSIL® | To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Incidence of Re-treatment at the TBS | 10 minutes after application | 0 Participants |
| TACHOSIL® | To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Incidence of Re-treatment at the TBS | 2 minutes after application (only for sFilm-FS) | 0 Participants |
| TACHOSIL® | To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Incidence of Re-treatment at the TBS | 3 minutes after application | 0 Participants |
| TACHOSIL® | To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Incidence of Re-treatment at the TBS | 5 minutes after application | 0 Participants |
| TACHOSIL® | To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Incidence of Re-treatment at the TBS | 7 minutes after application | 0 Participants |
Secondary
To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Percentage of Total Patients That Have Achieved Hemostasis
Percentage of total patients (patients that achieved hemostasis with a single patch application and patients that required additional patches) that have achieved hemostasis 10 minutes after first product application and therefore did not need to convert to standard of care treatment at the end of these 10 minutes
Time frame: Day of surgery
Population: Descriptive statistics of all randomized patients who underwent surgery, received at least one dose of study treatment and having no major violations of inclusion and exclusion criteria
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| sFilm-FS | To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Percentage of Total Patients That Have Achieved Hemostasis | 14 Participants |
| TACHOSIL® | To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Percentage of Total Patients That Have Achieved Hemostasis | 12 Participants |
Secondary
To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Proportion of Patients Achieving Hemostasis at TBS
Proportion of patients achieving hemostasis at TBS (absence of bleeding) at 2 (for sFilm-FS product only), 3, 5, 7 or 10 minutes following first product application, without the occurrence of re-bleeding, starting from 10 minutes after product application and until the completion of surgical closure
Time frame: Day of surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| sFilm-FS | To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Proportion of Patients Achieving Hemostasis at TBS | 3 minutes after application | 12 Participants |
| sFilm-FS | To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Proportion of Patients Achieving Hemostasis at TBS | 7 minutes after application | 12 Participants |
| sFilm-FS | To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Proportion of Patients Achieving Hemostasis at TBS | 5 minutes after application | 12 Participants |
| sFilm-FS | To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Proportion of Patients Achieving Hemostasis at TBS | 10 minutes after application | 14 Participants |
| sFilm-FS | To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Proportion of Patients Achieving Hemostasis at TBS | 2 minutes after application (only for sFilm-FS) | 11 Participants |
| TACHOSIL® | To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Proportion of Patients Achieving Hemostasis at TBS | 10 minutes after application | 12 Participants |
| TACHOSIL® | To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Proportion of Patients Achieving Hemostasis at TBS | 2 minutes after application (only for sFilm-FS) | 0 Participants |
| TACHOSIL® | To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Proportion of Patients Achieving Hemostasis at TBS | 3 minutes after application | 12 Participants |
| TACHOSIL® | To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Proportion of Patients Achieving Hemostasis at TBS | 5 minutes after application | 12 Participants |
| TACHOSIL® | To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Proportion of Patients Achieving Hemostasis at TBS | 7 minutes after application | 12 Participants |