PeproStat haemostat study in subjects undergoing liver surgery
Research type
Research Study
Full title
A Multi-centre, Open-label, Uncontrolled, First-in-Human Study to Evaluate the Safety and Tolerability and Explore the Efficacy of PeproStat in Gelita-Spon® Gelatin Sponge in Subjects Undergoing Open Liver Resection Surgery
IRAS ID
133094
Contact name
Darius Mirza
Contact email
Sponsor organisation
Haemostatix Ltd
Eudract number
2013-001993-10
Research summary
Bleeding during surgery is a common problem that may extend the time it takes to complete a procedure and can make it more difficult for the surgeon to see the operating site; it can also be associated with significant blood loss and even death.
Conventional methods to stop bleeding include manual pressure (placing a surgical pad onto the bleed site and firmly pressing down), cauterization (applying heat to close off the blood vessel that is bleeding), or sutures (stitching the wound closed). If these methods fail, surgeons can use a haemostat which they place directly onto the bleed site (Topical Haemostat). A haemostatic agent works by causing the blood to clot.
This is a study to test a new haemostatic agent called PeproStat for the first time in humans. PeproStat is a new class of topical haemostatic agent composed of recombinant human albumin conjugated with fibrinogen-binding peptides. PeproStat enables blood to clot at the bleed site without the need for thrombin, which is required in the normal blood clotting process.
PeproStat is formulated in a liquid, and is soaked into a haemostatic gelatin sponge in the operating theatre, and applied directly to the site of bleeding. PeproStat offers four potential benefits over current thrombin-based therapies: (i) animal trials indicate a significantly faster onset of action; and (ii) greater haemostatic efficacy (iii) the product is manufactured from blood-free components; (iv) the product has greater shelf-life stability compared to thrombin enabling the development of a greater range of ready-to-use formulations.
This study is primarily designed to assess the safety and tolerability, as well as to explore the efficacy of PeproStat when used in subjects undergoing open liver resection surgery.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
14/WM/0136
Date of REC Opinion
9 May 2014
REC opinion
Favourable Opinion