FINISH-3
Research type
Research Study
Full title
A Phase 3, Randomized, Single-Blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Haemostasis
IRAS ID
102908
Contact name
Gerard Stansby
Sponsor organisation
ProFibrix BV
Eudract number
2011-006174-47
Clinicaltrials.gov Identifier
Research summary
There are several standard treatments to stop bleeding during an operation, such as stitches, binding, sealing of tissue by heat, laser or use of a tissue glue (also called fibrin sealants). The choice depends on the situation, nature and seriousness of the bleeding. Fibrin sealants mimic the last stage of blood clotting by generating semi-rigid, cross-linked fibrin clots that bind the surface of injured tissues to seal surfaces, support sutures, and/or improve repair or healing of tissues. In current practice, typical fibrin sealants consist of human blood-derived thrombin and fibrinogen that are filled and stored separtely to avoid reactions before application to the intended site of action. Most commercially available products are stored frozen and must be thawed or reconstituted before they can be applied to a wound site. To improve the convenience and flexibility of use, Fibrocaps (Investigational Product) has been designed as room-temperature stable, ready-to-use powder fibrin sealant that dissolves and activates on contact when applied onto a bleeding or oozing wound site. A Fibrospray device can be used to help with application. Subjects will be randomly assigned to either the control group - gelatin sponge (commonly used to help stop bleeding) or treatment group with Fibrocaps (with or without use of device) in combination with a gelatin sponge. The main aim of this multi-centre study is to demonstrate the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone for stopping bleeding in subjects undergoing spinal surgery, hepatic resection, vascular surgery and soft tissue dessection surgery when control of mild to moderate bleeding by standard surgical techniques is ineffective and/or impractical. The study is being run in hospitals, with patients recruited into the study for approximately 6 weeks incorporating 4 study visits including surgery itself.
REC name
North East - York Research Ethics Committee
REC reference
12/NE/0181
Date of REC Opinion
30 May 2012
REC opinion
Further Information Favourable Opinion