Hemorrhage, Soft Tissue Bleeding
Conditions
Keywords
Fibrin Sealant, Hemostatics, Coagulants
Brief summary
To evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) as an adjunct to achieve haemostasis during surgery in paediatric patients.
Detailed description
This is a prospective, randomized, controlled, clinical study comparing EVICEL® to SURGICEL®, as an adjunct to haemostasis when conventional methods of controlling bleeding are ineffective or impractical during surgery in paediatric patients. At least 40 qualified paediatric subjects with an appropriate mild or moderate Target Bleeding Site (TBS) will be randomized in a 1:1 allocation ratio to either EVICEL® or SURGICEL®. Haemostasis will be assessed at 4, 7 and 10 minutes from randomization. Enrolment will be staggered by age (as required by the European Medicines Agency (EMA) Paediatric Committee). The first group enrolled will include at least 36 subjects aged ≥1 years to \<18 years of age. When enrolment of the first group is complete; enrolment of a subsequent group will commence and include at least 4 subjects from birth (including neonates ≤37 weeks gestation) to \<1 years of age. Subjects will be followed post-operatively through hospital discharge and at 30 days (±14 days) post-surgery.
Interventions
BIOLOGICALEVICEL® Fibrin Sealant
EVICEL® is a human plasma-derived fibrin sealant. EVICEL® consists of two components: a concentrate of Human Clottable Protein (referred to as Biological Component 2; BAC2) and a solution of Human Thrombin. No material of animal origin is present in the product
DEVICESURGICEL® Absorbable Hemostat
SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
Sponsors
Ethicon, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
Inclusion criteria
* Paediatric subjects birth to \<18 years of age, requiring non-emergent laparoscopic or open (through peritoneum or pleura) abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures. i) The first 36 subjects to be enrolled will be subjects ≥1 years to \<18 years of age. ii) The next 4 subjects to be enrolled will be subjects birth to \<1years of age. * The subject and/or subject's parent or legal guardian must be willing to give permission for the subject to participate in the trial, and provide written informed consent for the subject. If possible, assent must be obtained from paediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the trial. If the paediatric subject is not able to provide assent (due to age, maturity and/or inability to intellectually and/or emotionally comprehend the trial), the parent/legal guardian's written informed consent for the subject will be acceptable for the subject to be included in the study; and * Presence of an appropriate mild or moderate bleeding soft tissue or parenchymal organ Target Bleeding Site identified intra-operatively by the surgeon;
Exclusion criteria
* Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products; * Female subjects, who are of childbearing age (i.e. adolescent), who are pregnant or nursing; * Subject is currently participating or, during the study is planned to participate in any other investigational device or drug trial without prior approval from the Sponsor; * Subjects who are known, current alcohol and/or drug abusers; * Subjects admitted for trauma surgery; * Subjects with any pre or intra-operative findings identified by the surgeon that may preclude conduct of the study procedure; * Subjects with Target Bleeding Site in an actively infected field (Class III Contaminated or Class IV Dirty or Infected) * Anastomotic bleeding sites will not be considered for randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Time to Haemostasis | From randomisation (identification of appropriate target bleeding site) to final fascial closure (median study procedure time 164.0 minutes [range 47.0 - 506.0 minutes]) | Absolute time to haemostasis, defined as absolute time when there was no detectable bleeding at the Target Bleeding Site (TBS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving Haemostasis at 4 Minutes | Intra-operatively from randomisation to 4 minutes after randomisation | Number of participants achieving haemostasis at target bleeding site at 4 minutes. This endpoint is assessing haemostasis at 4 minutes only and not maintenance of haemostasis following this timepoint. As rebleeding may occur between timepoints, subsequent rebleeding (if any) is detailed in treatment failure analysis. |
| Number of Participants Achieving Haemostasis at 7 Minutes | Intra-operatively from randomisation to 7 minutes after randomisation | Number of Participants Achieving Haemostasis at Target Bleeding Site at 7 Minutes. This endpoint is assessing haemostasis at 7 minutes only and is not affected by haemostasis assessment prior to 7 minutes or maintenance of haemostasis following this 7 minute assessment. As rebleeding may occur between timepoints, subsequent rebleeding (if any) is detailed in treatment failure analysis. |
| Number of Participants Achieving Haemostasis at 10 Minutes | Intra-operatively from randomisation to 10 minutes after randomisation | Number of Participants Achieving Haemostasis at Target Bleeding Site at 10 Minutes. This endpoint is assessing haemostasis at 10 minutes only and is not affected by haemostasis assessments prior to 10 minutes or maintenance of haemostasis following this 10 minute assessment. As rebleeding may occur between timepoints, subsequent rebleeding (if any) is detailed in treatment failure analysis). |
| Incidence of Treatment Failures (Number of Participants) | 10 minutes | Defined as haemostasis not achieved within 10 minutes or bleeding requiring treatment other than re-application of the assigned haemostatic adjunct within 10 minutes. |
| Estimated Blood Loss | During surgical procedure (first incision to final fascial closure (median study procedure time 164.0 minutes [range 47.0 - 506.0 minutes]) | Blood loss during surgical procedure (includes but not limited to the target bleeding site) |
| Blood Transfusion | From surgical procedure to 30 day (+/-14 day) follow-up visit | Participants requiring a blood transfusion |
| Participants Receiving a Blood Transfusion | From surgery to 30 day (+/-14 day) follow-up visit | Details of blood products received (if any) |
| Changes in Laboratory Parameters Haemoglobin and Mean Corpuscular Haemoglobin Concentration | Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge) | Laboratory parameter changes from baseline to post operative hospital discharge (Haemoglobin and Mean Corpuscular Haemoglobin Concentration) |
| Changes in Laboratory Parameters Activated Partial Thromboplastin Time and Prothrombin Time | Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge) | Laboratory parameter changes from baseline to post operative hospital discharge (Activated Partial Thromboplastin Time and Prothrombin Time) |
| Changes in Laboratory Parameters International Normalised Ratio | Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge) | Standardized measurement of the change in blood clotting time from baseline to post operative hospital discharge |
| Changes in Laboratory Parameters Haematocrit | Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge) | Change in red blood cell proportion in volume in the blood from baseline to post operative hospital discharge |
| Changes in Laboratory Parameters Platelet Count and White Cell Count | Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours) | Laboratory parameter changes from baseline to post operative hospital discharge |
| Changes in Laboratory Parameters Red Blood Cell Count | Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge) | Laboratory parameter changes from baseline to post operative hospital discharge |
| Changes in Laboratory Parameters Mean Corpuscular Haemoglobin | Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge) | Laboratory parameter changes from baseline to post operative hospital discharge |
| Changes in Laboratory Parameters Mean Corpuscular Volume | Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge) | Laboratory parameter changes from baseline to post operative hospital discharge |
| Changes in Laboratory Parameters Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge) | Laboratory parameter changes in volume from baseline to post operative hospital discharge (Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Adverse Event Related to Re-bleeding at Target Bleeding Site | From randomisation to 30 days (+/- 14 days) following surgery | Number of Participants with an Adverse Event Related to Re-bleeding at Target Bleeding Site. |
| Number of Participants With a Thrombotic Event | From randomisation up to 30 days (+/- 14 days) following surgery | Number of Participants with a Thrombotic Event. |
Countries
Belgium, Canada, United Kingdom
Participant flow
Recruitment details
Subjects were screened up to 21 days prior to surgery and attended a baseline visit within 24 hours of surgery. Both visits took place at a clinic within the hospital where surgery also took place. Subjects were followed until discharge and requested to attend a visit at 30 days (+/- 14 days) post surgery either at the hospital or via telephone.
Pre-assignment details
Subjects required to meet pre-defined inclusion/exclusion criteria prior to randomization. Subjects required to have an appropriate mild or moderate target bleeding site identified intra-operatively. Subjects were excluded if the target bleeding site was in an actively infected field or if the bleeding was at an anastomotic bleeding site.
Participants by arm
| Arm | Count |
|---|---|
| EVICEL® EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin. | 20 |
| SURGICEL® SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | EVICEL® | SURGICEL® | Total |
|---|---|---|---|
| Age, Continuous | 9.4 Years | 9.0 Years | 9.2 Years |
| Age, Customized Adolescents (12-17 years) | 11 Participants | 9 Participants | 20 Participants |
| Age, Customized Children (2-11 years) | 4 Participants | 9 Participants | 13 Participants |
| Age, Customized Infants and toddlers (31 days-<24 months) | 5 Participants | 2 Participants | 7 Participants |
| Age, Customized Neonate (Birth to 30 Days) | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized White/Caucasian | 16 Participants | 16 Participants | 32 Participants |
| Sex: Female, Male Female | 11 Participants | 7 Participants | 18 Participants |
| Sex: Female, Male Male | 9 Participants | 13 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 18 / 20 | 20 / 20 |
| serious Total, serious adverse events | 4 / 20 | 3 / 20 |
Outcome results
Primary
Absolute Time to Haemostasis
Absolute time to haemostasis, defined as absolute time when there was no detectable bleeding at the Target Bleeding Site (TBS).
Time frame: From randomisation (identification of appropriate target bleeding site) to final fascial closure (median study procedure time 164.0 minutes [range 47.0 - 506.0 minutes])
Population: Full Analysis Set (all randomized subjects)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EVICEL® | Absolute Time to Haemostasis | 4.0 Minutes |
| SURGICEL® | Absolute Time to Haemostasis | 4.0 Minutes |
Secondary
Blood Transfusion
Participants requiring a blood transfusion
Time frame: From surgical procedure to 30 day (+/-14 day) follow-up visit
Population: Full Analysis Set (all randomized subjects)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EVICEL® | Blood Transfusion | Yes (Blood Transfusion Received) | 7 Participants |
| EVICEL® | Blood Transfusion | No (Blood Transfusion Not Received) | 13 Participants |
| SURGICEL® | Blood Transfusion | Yes (Blood Transfusion Received) | 3 Participants |
| SURGICEL® | Blood Transfusion | No (Blood Transfusion Not Received) | 17 Participants |
Secondary
Changes in Laboratory Parameters Activated Partial Thromboplastin Time and Prothrombin Time
Laboratory parameter changes from baseline to post operative hospital discharge (Activated Partial Thromboplastin Time and Prothrombin Time)
Time frame: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Population: Safety Set (all subjects who received treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EVICEL® | Changes in Laboratory Parameters Activated Partial Thromboplastin Time and Prothrombin Time | Activated Partial Thromboplastin Time seconds | -0.9 Seconds | Standard Deviation 4.2 |
| EVICEL® | Changes in Laboratory Parameters Activated Partial Thromboplastin Time and Prothrombin Time | Prothrombin Time seconds | 0.7 Seconds | Standard Deviation 3 |
| SURGICEL® | Changes in Laboratory Parameters Activated Partial Thromboplastin Time and Prothrombin Time | Activated Partial Thromboplastin Time seconds | -2.2 Seconds | Standard Deviation 4.2 |
| SURGICEL® | Changes in Laboratory Parameters Activated Partial Thromboplastin Time and Prothrombin Time | Prothrombin Time seconds | 0.1 Seconds | Standard Deviation 1.3 |
Secondary
Changes in Laboratory Parameters Haematocrit
Change in red blood cell proportion in volume in the blood from baseline to post operative hospital discharge
Time frame: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Population: Safety Set (all subjects who received treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EVICEL® | Changes in Laboratory Parameters Haematocrit | -0.0 L/L | Standard Deviation 0 |
| SURGICEL® | Changes in Laboratory Parameters Haematocrit | -0.0 L/L | Standard Deviation 0 |
Secondary
Changes in Laboratory Parameters Haemoglobin and Mean Corpuscular Haemoglobin Concentration
Laboratory parameter changes from baseline to post operative hospital discharge (Haemoglobin and Mean Corpuscular Haemoglobin Concentration)
Time frame: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Population: Safety Set (all subjects who received treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EVICEL® | Changes in Laboratory Parameters Haemoglobin and Mean Corpuscular Haemoglobin Concentration | Haemoglobin g/L | -13.2 g/L | Standard Deviation 21.5 |
| EVICEL® | Changes in Laboratory Parameters Haemoglobin and Mean Corpuscular Haemoglobin Concentration | Mean Corpuscular Haemoglobin Concentration g/L | -5.3 g/L | Standard Deviation 6.7 |
| SURGICEL® | Changes in Laboratory Parameters Haemoglobin and Mean Corpuscular Haemoglobin Concentration | Haemoglobin g/L | -10.6 g/L | Standard Deviation 8.9 |
| SURGICEL® | Changes in Laboratory Parameters Haemoglobin and Mean Corpuscular Haemoglobin Concentration | Mean Corpuscular Haemoglobin Concentration g/L | -3.4 g/L | Standard Deviation 11.9 |
Secondary
Changes in Laboratory Parameters International Normalised Ratio
Standardized measurement of the change in blood clotting time from baseline to post operative hospital discharge
Time frame: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Population: Safety Set (all subjects who received treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EVICEL® | Changes in Laboratory Parameters International Normalised Ratio | 0.1 Ratio | Standard Deviation 0.2 |
| SURGICEL® | Changes in Laboratory Parameters International Normalised Ratio | -0.0 Ratio | Standard Deviation 0.1 |
Secondary
Changes in Laboratory Parameters Mean Corpuscular Haemoglobin
Laboratory parameter changes from baseline to post operative hospital discharge
Time frame: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Population: Safety Set (all subjects who received treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EVICEL® | Changes in Laboratory Parameters Mean Corpuscular Haemoglobin | -0.1 pg | Standard Deviation 1.1 |
| SURGICEL® | Changes in Laboratory Parameters Mean Corpuscular Haemoglobin | 0.2 pg | Standard Deviation 0.9 |
Secondary
Changes in Laboratory Parameters Mean Corpuscular Volume
Laboratory parameter changes from baseline to post operative hospital discharge
Time frame: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Population: Safety Set (all subjects who received treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EVICEL® | Changes in Laboratory Parameters Mean Corpuscular Volume | 0.9 f/L | Standard Deviation 2.6 |
| SURGICEL® | Changes in Laboratory Parameters Mean Corpuscular Volume | 1.5 f/L | Standard Deviation 3.2 |
Secondary
Changes in Laboratory Parameters Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Laboratory parameter changes in volume from baseline to post operative hospital discharge (Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils)
Time frame: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Population: Safety Set (all subjects who received treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EVICEL® | Changes in Laboratory Parameters Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Neutrophils % | 9.0 Percent Volume | Standard Deviation 17.1 |
| EVICEL® | Changes in Laboratory Parameters Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Lymphocytes % | -7.2 Percent Volume | Standard Deviation 13.1 |
| EVICEL® | Changes in Laboratory Parameters Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Monocytes % | -0.8 Percent Volume | Standard Deviation 6.4 |
| EVICEL® | Changes in Laboratory Parameters Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Basophils % | -0.1 Percent Volume | Standard Deviation 0.4 |
| SURGICEL® | Changes in Laboratory Parameters Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Basophils % | -0.3 Percent Volume | Standard Deviation 0.4 |
| SURGICEL® | Changes in Laboratory Parameters Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Neutrophils % | 10.1 Percent Volume | Standard Deviation 19.4 |
| SURGICEL® | Changes in Laboratory Parameters Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Monocytes % | 1.5 Percent Volume | Standard Deviation 2.1 |
| SURGICEL® | Changes in Laboratory Parameters Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Lymphocytes % | -11.6 Percent Volume | Standard Deviation 17.3 |
Secondary
Changes in Laboratory Parameters Platelet Count and White Cell Count
Laboratory parameter changes from baseline to post operative hospital discharge
Time frame: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours)
Population: Safety Set (all subjects who received treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EVICEL® | Changes in Laboratory Parameters Platelet Count and White Cell Count | Platelet Count *10^9/L | 27.4 Cells*10^9/L | Standard Deviation 159.3 |
| EVICEL® | Changes in Laboratory Parameters Platelet Count and White Cell Count | White Blood Cell Count *10^9/L | 2.0 Cells*10^9/L | Standard Deviation 5.2 |
| SURGICEL® | Changes in Laboratory Parameters Platelet Count and White Cell Count | Platelet Count *10^9/L | 7.6 Cells*10^9/L | Standard Deviation 96.3 |
| SURGICEL® | Changes in Laboratory Parameters Platelet Count and White Cell Count | White Blood Cell Count *10^9/L | 1.4 Cells*10^9/L | Standard Deviation 4.3 |
Secondary
Changes in Laboratory Parameters Red Blood Cell Count
Laboratory parameter changes from baseline to post operative hospital discharge
Time frame: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Population: Safety Set (all subjects who received treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EVICEL® | Changes in Laboratory Parameters Red Blood Cell Count | -0.3 Cells*10^12/L | Standard Deviation 0.5 |
| SURGICEL® | Changes in Laboratory Parameters Red Blood Cell Count | -0.4 Cells*10^12/L | Standard Deviation 0.4 |
Secondary
Estimated Blood Loss
Blood loss during surgical procedure (includes but not limited to the target bleeding site)
Time frame: During surgical procedure (first incision to final fascial closure (median study procedure time 164.0 minutes [range 47.0 - 506.0 minutes])
Population: Full Analysis Set (all randomized subjects)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EVICEL® | Estimated Blood Loss | 50.0 mL |
| SURGICEL® | Estimated Blood Loss | 50.0 mL |
Secondary
Incidence of Treatment Failures (Number of Participants)
Defined as haemostasis not achieved within 10 minutes or bleeding requiring treatment other than re-application of the assigned haemostatic adjunct within 10 minutes.
Time frame: 10 minutes
Population: Full Analysis Set (all randomized subjects) Note: Two subjects in the control arm were haemostatic at the TBS at 10 minutes however they subsequently rebled requiring additional treatment and were conservatively considered a failure for the secondary endpoint of Incidence of Treatment Failures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EVICEL® | Incidence of Treatment Failures (Number of Participants) | 1 Participants |
| SURGICEL® | Incidence of Treatment Failures (Number of Participants) | 5 Participants |
Secondary
Number of Participants Achieving Haemostasis at 10 Minutes
Number of Participants Achieving Haemostasis at Target Bleeding Site at 10 Minutes. This endpoint is assessing haemostasis at 10 minutes only and is not affected by haemostasis assessments prior to 10 minutes or maintenance of haemostasis following this 10 minute assessment. As rebleeding may occur between timepoints, subsequent rebleeding (if any) is detailed in treatment failure analysis).
Time frame: Intra-operatively from randomisation to 10 minutes after randomisation
Population: Full Analysis Set (all randomized subjects)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EVICEL® | Number of Participants Achieving Haemostasis at 10 Minutes | 19 Participants |
| SURGICEL® | Number of Participants Achieving Haemostasis at 10 Minutes | 18 Participants |
Secondary
Number of Participants Achieving Haemostasis at 4 Minutes
Number of participants achieving haemostasis at target bleeding site at 4 minutes. This endpoint is assessing haemostasis at 4 minutes only and not maintenance of haemostasis following this timepoint. As rebleeding may occur between timepoints, subsequent rebleeding (if any) is detailed in treatment failure analysis.
Time frame: Intra-operatively from randomisation to 4 minutes after randomisation
Population: Full Analysis Set (all randomized subjects)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EVICEL® | Number of Participants Achieving Haemostasis at 4 Minutes | 16 Participants |
| SURGICEL® | Number of Participants Achieving Haemostasis at 4 Minutes | 13 Participants |
Secondary
Number of Participants Achieving Haemostasis at 7 Minutes
Number of Participants Achieving Haemostasis at Target Bleeding Site at 7 Minutes. This endpoint is assessing haemostasis at 7 minutes only and is not affected by haemostasis assessment prior to 7 minutes or maintenance of haemostasis following this 7 minute assessment. As rebleeding may occur between timepoints, subsequent rebleeding (if any) is detailed in treatment failure analysis.
Time frame: Intra-operatively from randomisation to 7 minutes after randomisation
Population: Full Analysis Set (all randomized subjects)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EVICEL® | Number of Participants Achieving Haemostasis at 7 Minutes | 20 Participants |
| SURGICEL® | Number of Participants Achieving Haemostasis at 7 Minutes | 16 Participants |
Secondary
Participants Receiving a Blood Transfusion
Details of blood products received (if any)
Time frame: From surgery to 30 day (+/-14 day) follow-up visit
Population: Full Analysis Set (all randomized subjects with data)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EVICEL® | Participants Receiving a Blood Transfusion | Fresh Frozen Plasma 0 Units | 6 Participants |
| EVICEL® | Participants Receiving a Blood Transfusion | Packed Red Blood Cells 2 Units | 0 Participants |
| EVICEL® | Participants Receiving a Blood Transfusion | Fresh Frozen Plasma 1 Unit | 0 Participants |
| EVICEL® | Participants Receiving a Blood Transfusion | Whole Blood 0 Units | 4 Participants |
| EVICEL® | Participants Receiving a Blood Transfusion | Fresh Frozen Plasma 2 Units | 1 Participants |
| EVICEL® | Participants Receiving a Blood Transfusion | Platelets 0 Units | 6 Participants |
| EVICEL® | Participants Receiving a Blood Transfusion | Whole Blood 1 Unit | 0 Participants |
| EVICEL® | Participants Receiving a Blood Transfusion | Platelets 1 Unit | 1 Participants |
| EVICEL® | Participants Receiving a Blood Transfusion | Packed Red Blood Cells 1 Unit | 4 Participants |
| EVICEL® | Participants Receiving a Blood Transfusion | Cryoprecipitates 0 Units | 7 Participants |
| EVICEL® | Participants Receiving a Blood Transfusion | Whole Blood 2 Units | 3 Participants |
| EVICEL® | Participants Receiving a Blood Transfusion | Other 0 Units | 7 Participants |
| EVICEL® | Participants Receiving a Blood Transfusion | Packed Red Blood Cells 0 Units | 3 Participants |
| SURGICEL® | Participants Receiving a Blood Transfusion | Other 0 Units | 3 Participants |
| SURGICEL® | Participants Receiving a Blood Transfusion | Packed Red Blood Cells 2 Units | 2 Participants |
| SURGICEL® | Participants Receiving a Blood Transfusion | Packed Red Blood Cells 0 Units | 0 Participants |
| SURGICEL® | Participants Receiving a Blood Transfusion | Packed Red Blood Cells 1 Unit | 1 Participants |
| SURGICEL® | Participants Receiving a Blood Transfusion | Whole Blood 0 Units | 3 Participants |
| SURGICEL® | Participants Receiving a Blood Transfusion | Whole Blood 1 Unit | 0 Participants |
| SURGICEL® | Participants Receiving a Blood Transfusion | Whole Blood 2 Units | 0 Participants |
| SURGICEL® | Participants Receiving a Blood Transfusion | Fresh Frozen Plasma 0 Units | 3 Participants |
| SURGICEL® | Participants Receiving a Blood Transfusion | Fresh Frozen Plasma 1 Unit | 0 Participants |
| SURGICEL® | Participants Receiving a Blood Transfusion | Platelets 0 Units | 3 Participants |
| SURGICEL® | Participants Receiving a Blood Transfusion | Platelets 1 Unit | 0 Participants |
| SURGICEL® | Participants Receiving a Blood Transfusion | Cryoprecipitates 0 Units | 3 Participants |
| SURGICEL® | Participants Receiving a Blood Transfusion | Fresh Frozen Plasma 2 Units | 0 Participants |
Other Pre-specified
Number of Participants With an Adverse Event Related to Re-bleeding at Target Bleeding Site
Number of Participants with an Adverse Event Related to Re-bleeding at Target Bleeding Site.
Time frame: From randomisation to 30 days (+/- 14 days) following surgery
Population: Safety Set (all subjects who received treatment)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EVICEL® | Number of Participants With an Adverse Event Related to Re-bleeding at Target Bleeding Site | Subjects with AE related to re-bleeding at TBS | 1 Participants |
| SURGICEL® | Number of Participants With an Adverse Event Related to Re-bleeding at Target Bleeding Site | Subjects with AE related to re-bleeding at TBS | 2 Participants |
Other Pre-specified
Number of Participants With a Thrombotic Event
Number of Participants with a Thrombotic Event.
Time frame: From randomisation up to 30 days (+/- 14 days) following surgery
Population: Safety Set (all subjects who received treatment)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EVICEL® | Number of Participants With a Thrombotic Event | Number of subjects with thrombotic events | 0 Participants |
| SURGICEL® | Number of Participants With a Thrombotic Event | Number of subjects with thrombotic events | 0 Participants |