A Phase III Randomized, Controlled, Superiority Study Evaluating the Fibrin Pad Versus Standard of Care Treatment in Controlling Severe Soft Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic Surgery - The Severe Soft Tissue Bleeding Study
- Conditions
- Patients undergoing abdominal, pelvic, retroperitoneal, and (non-cardiac) thoracic surgery.
- Registration Number
- EUCTR2008-004835-39-DE
- Lead Sponsor
- OMRIX biopharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
1.Subjects > 18 years of age, requiring non-emergent, open abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures;
2.Presence of an appropriate severe bleeding soft tissue 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
1.Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure;
2.Bleeding site is from large defects in arteries or veins 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. Subject with TBS within an actively infected field;
4.Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine;
5.Subjects with known intolerance to blood products or to one of the components of the study product;
6.Subjects unwilling to receive blood products;
7.Subjects with immunodeficiency diseases (including known HIV);
8.Subjects who are known, current alcohol and / or drug abusers;
9. Subjects who have participated in another investigational drug or device research study within 30 days of enrollment;
10.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 haemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling severe soft tissue bleeding during abdominal, pelvic, retroperitoneal, and (non-cardiac) thoracic surgery.;Secondary Objective: N/A;Primary end point(s): The proportion of subjects achieving hemostasis at the TBS at 4-minutes following randomization and with no re-bleeding at the TBS anytime prior to wound closure. Haemostasis is defined as no detectable bleeding at the TBS.
- Secondary Outcome Measures
Name Time Method