A clinical study to test the Fibrin Pad versus standard of care treatment
- Conditions
- Subjects undergoing elective, open, hepatic surgery during which a resection plane is created and wherein an appropriate Target Bleeding Site is identified.MedDRA version: 14.0Level: PTClassification code 10068093Term: Gastrointestinal surgerySystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Body processes [G] - Biological Phenomena [G16]
- Registration Number
- EUCTR2010-019427-58-GB
- Lead Sponsor
- Omrix Biopharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
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 Fibrin Pad 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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-miniutes 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 FP will be visible to confirm hemostasis).;Timepoint(s) of evaluation of this end point: 4 minutes; any time prior to the initiation of wond closure
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Proportion of subjects achieving hemostatic success at 10 minutes following randomization; (defined as achievement of hemostasis at 10 minutes and no further bleeding requiring re-treatment prior to wound closure);Timepoint(s) of evaluation of this end point: 10 minutes;