CLOTFAST II
Research type
Research Study
Full title
A controlled, randomized, multi-centre, double blind, phase II study to evaluate efficacy and safety of topical PeproStat in intraoperative surgical haemostasis
IRAS ID
217214
Contact name
Paul Hayes
Contact email
Sponsor organisation
Haemostatix Ltd
Eudract number
2016-003661-26
Duration of Study in the UK
0 years, 8 months, 0 days
Research summary
The aim of the study is to look at the effectiveness of the study drug (PeproStat) at controlling bleeding that occurs during surgery that cannot be controlled by usual methods. Adult patients undergoing open liver/soft tissue surgery, vascular surgery or spine surgery are eligible for the study which will be conducted in hospitals in the UK and other EU and non EU countries. The study will last 6-8 weeks for each participant and approximately 8 months overall. the participants will undergo checks to ensure they are eligible and if they give consent, they will undergo their routine planned surgery. If required, PeproStat or saline soaked into a gelatine sponge will be applied with during the operation and assessments will be performed by the surgeons in accordance with the protocol. These participants will undergo study assessments 1 day after surgery, at discharge and at Day 30. Patients that did not require treatment with PeproStat/saline will not undergo the follow-up visits and will be recorded as an extended screen failure.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
16/EE/0526
Date of REC Opinion
16 Feb 2017
REC opinion
Further Information Favourable Opinion