Open hepatic surgery, with presence of an target bleeding site (TBS). MedDRA version: 21.1 Level: LLT Classification code 10067440 Term: Hemostasis System Organ Class: 100000004865
Conditions
Sponsors
Sealantium Medical Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients (males or females) aged = 18 years old. 2. Patients requiring elective surgery in which liver bleeding will be encountered.. 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 surgery in which liver bleeding will be encountered. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion 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 exclusion criteria: 15. Patients identified with a TBS with major arterial bleeding requiring suture or mechanical ligation. 16. Patients identified by the Investigator to have intra-operative bleeding from large defects in large arteries or veins, requiring repair. 17. Patients identified by the Investigator to have intra-operative findings that may preclude conduct of study procedure. 18. Patients having an active local infection in the anatomic surgical area. 19. Patients with occurrence of major intra-operative complications that require resuscitation or deviation from the planned surgical procedure. 20. Patients with bleeding site in or near to foramina in bone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: - Vital Signs and Hematology parameters will be evaluated from screening visit (V1) from Follow-up visits (V2, V3, V4, V5, V6, V7, V8, V9). - Physical Examination will be evaluated from Screening (V1) and Baseline (V2) visits, and from Hospital Discharge (V5) to Follow-up visits (V6, V7, V8, V9). - Urine analysis and coagulation parameters will be evaluated from Screnning to Surgery visits (V1, V2, V3) and from Hospital Discharge to Follow-up visits (V5, V6, V9). -Adverse Events will be evaluated from Surgery visit (V3) to Follow-up visits (V4, V5, V6, V7, V8, V9) ;Primary end point(s): The primary end-point of the study is the evaluation of safety. Safety will be assessed from randomization of patients until the last follow-up visit and will include evaluation of treatment emergent adverse events. In particular, patients will be followed for AEs related to bleeding at TBS, thrombotic events, transfusion-related complications, postoperative adhesions (MRI assessment) as well as vital signs, physical examination, urine analysis, blood / coagulation parameters profiles, antibodies against fibrinogen and thrombin, and signs of systemic inflammation.;Main Objective: The primary objective of this study is to evaluate the safety of sFilm-FS versus an active-comparator (TACHOSIL®) when used as adjunct to conventional hemostatic techniques during elective hepatic surgery.;Secondary Objective: The secondary objective of this study is to preliminarily evaluate the hemostatic efficacy of sFilm-FS in controlling parenchymal bleeding during surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints of the study are: 1) 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. 2) 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). 3) Time to Hemostasis from first product application (TTHP). Time to Hemostasis from patient randomization (TTHR) will be collected as well but will not be used as endpoint. 4) 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. 5) Incidence of treatment failure, based on pre-defined treatment failure criteria. 6) Incidence of transfusion requirements in the 6 months follow-up period.;Timepoint(s) of evaluation of this end point: 1) Visit 3. 2) Visit 3. 3) Visit 3. 4) Visit 3. 5) Visit 3. 6) Visit 3 to Visit 9. | — |
Countries
Austria, Slovenia, United States
Contacts
Public ContactClinical Operations
Sintesi Research Srl
Outcome results
None listed