Prospective Observational Study of Purastat in Gastrointestinal Bleeds
Research type
Research Study
Full title
A Multicentre Prospective Observational Study to evaluate the Utilisation, Effectiveness and Safety of Purastat in the Management of Gastrointestinal Bleeding
IRAS ID
244526
Contact name
Pradeep Bhandari
Contact email
Sponsor organisation
Portsmouth Hospitals NHS Trust
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
The gastrointestinal tract and its lining are supplied by many blood vessels. Bleeding within the gastrointestinal tract can arise in several circumstances for instance from peptic ulcers, early cancer, abnormal vessels and during endoscopic procedures where pre-cancerous or cancerous abnormalities are removed. The usual method of treating bleeding using the endoscope in the gastrointestinal tract involves heat therapy or the placement of small metallic clips over the bleeding point. Precise targeting of heat therapy may be difficult and there is a risk that heat damage may occur resulting in a tear in the gastrointestinal lining. Placement of metallic clips to stop bleeding may interfere with the complete removal of a pre-cancerous or cancerous area.
Purastat is a synthetic liquid applied through the endoscope to the bleeding area. It is a transparent gel that coats the bleeding point and forms a barrier to prevent further bleeding. It may also reduce the risk of a bleed that occurs in a delayed fashion after the initial endoscopy. We wish to study its application in stopping bleeding within the gastrointestinal tract in a range of circumstances where bleeding can occur in this area.
Eligible patients who receive Purastat during endoscopic procedures for the control of or prevention of bleeding will be included in the study. Information on the type of procedure, bleeding encountered and treatment of bleeding including the effectiveness and use of Purastat will be collected. This information will help us understand how best to use Purastat to achieve its maximum potential in controlling bleeding.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
18/ES/0093
Date of REC Opinion
16 Aug 2018
REC opinion
Further Information Favourable Opinion