A new multicentre randomised controlled trial has started in Germany to evaluate PuraStat efficacy in preventing delayed bleeding after endoscopic resections.
The clinical investigation “Prospective, multicentre randomised controlled trial of the self-assembling haemostatic gel PuraStat to prevent delayed bleeding after endoscopic resections” is now live.
Clinically, significant delayed bleeding represents one of the most common complications after endoscopic resection of large gastrointestinal polyps.
Delayed bleedings could lead to a prolonged hospital stay, need for reintervention, need for transfusion of blood product as well as patient discomfort.
This national RCT study will involve at least 10 centres in Germany and enrol 248 participants. The purpose of the trial is to investigate the reduction of delayed bleeding rates in patients undergoing endoscopic hot snare resection in the colorectum or duodenum by using PuraStat. Furthermore, the study will evaluate PuraStat’s effect on complications other than bleeding, including wound healing, and recurrence.
DRKS - German Clinical Trials Register: DRKS-ID: DRKS00028119