Subjects undergoing elective, open, hepatic surgery during which a resection plane is created and wherein an appropriate Target Bleeding Site is identified. MedDRA version: 12.1 Level: LLT Classification code 10068093 Term: Gastrointestinal surgery
Conditions
Interventions
Product Name: Fibrin Pad
Product Code: Not applicable
Pharmaceutical Form: Impregnated pad
INN or Proposed INN: Human Fibrinogen
Other descriptive name: Fibrinogen
Concentration unit: Other
Concentrat
Sponsors
Omrix Biopharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects > 18 years of age, requiring elective or urgent open hepatic surgery 2. Presence of an appropriate bleeding parenchymal Target Bleeding Site (TBS) as identified intra-operatively by the surgeon. 3. Subjects must be willing to participate in the study, and provide written informed consent. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure; 2. TBS is from large defects in arteries or vein where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of the FP to blood flow and pressure during healing and absorption of the product; 3. TBS with major arterial bleeding requiring suture or mechanical ligation; 4. Subjects admitted for trauma surgery; 5. Subject is a transplant patient for fulminant hepatic failure; 6. Subject with TBS within an actively infected field; 7. Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine. 8. Subjects with known intolerance to blood products or to one of the components of the study product; 9. Subjects who are known, current alcohol and / or drug abusers; 10. Subjects who have participated in another investigational drug or device research study within 30 days of surgery; 11. Female subjects who are pregnant or nursing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the safety and hemostatic effectiveness of Fibrin Pad versus Standard of Care treatment in controlling parenchymal bleeding during hepatic surgery.;Secondary Objective: Not applicable;Primary end point(s): The proportion of subjects achieving hemostasis at the TBS at 4-minutes following randomization and with no re-bleeding requiring treatment at the TBS any time prior to the initiation of wound closure (last point in time where Fibrin Pad will be visible to confirm hemostasis). | — |
Countries
Germany, Netherlands, United Kingdom
Outcome results
None listed