Purastat for the treatment of haemorrhagic radiation proctopathy
Research type
Research Study
Full title
Endoscopically-delivered Purastat for the treatment of haemorrhagic radiation proctopathy: a randomised feasibility study
IRAS ID
254308
Contact name
Caroline Henson
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 4 months, 24 days
Research summary
Research Summary
30,000 people in the UK are treated with pelvic radiotherapy each year. Rectal bleeding is a common symptom side effect caused by radiation proctopathy (RP). RP is due to the effect of radiation on the rectum (back passage) which causes poor blood supply (ischaemia) which leads to stiffness/scarring (fibrosis) and the development of abnormal blood vessels on the surface of the lining of the rectum (telangiectasia) which can bleed (1, 2).
Six percent of patients will develop severe bleeding from RP (3), passing large amounts of blood and clots, often leading anaemia (low blood count) requiring either tablet or intravenous (IV) iron replacement, or blood transfusion. There are very few safe, effective, evidence-based treatments available for RP.
Purastat® is a new haemostatic agent (treatment that stops bleeding) which is licensed to treat bleeding from blood vessels in the gut. It is a liquid containing four peptides (protein building-blocks). When this liquid comes in contact with blood these peptides join together to form a mesh which closes the broken blood vessel thereby stopping the bleeding (4-7). Purastat is safe with no side effects and it breaks down amino acids, which are tissue building blocks that can be used to repair the site of injury (7). There are many studies which show that Purastat® is effective at stopping bleeding quickly and safely (within 10-20 seconds) (6-13). Early data from a case series of 21 patients by the research team has shown improvement in symptoms and endoscopic appearance.
This study is a dual site randomised feasibility study of 80 patients. It will obtain initial data into the safety and efficacy Purastat in reducing bleeding in people with severe haemorrhagic RP. These data will be used to support funding for an definitive randomised controlled trial.Summary of Results
30,000 people in the UK are treated with pelvic radiotherapy each year which often leads to cancer cure. Six in 100 people will get serious bleeding from abnormal blood vessels in the back passage caused by radiotherapy (radiation proctopathy (RP)). Purastat is a liquid containing natural protein building-blocks which has been shown to be helpful in reducing bleeding in RP and safe.
We want to see whether Purastat can treat bleeding from RP. The first step was this "feasibility" study to run study on a small scale to check that the full study would work.
People with bleeding from RP referred to 3 hospitals (Manchester, Liverpool and London) were invited to participate in the study. They were randomised to have either Purastat or standard treatment (sucralfate enemas). Information was collected with bleeding diaries; camera scores and blood tests. Side effects were recorded.
This study gave us important information about how to run the full study. It also showed that Purastat is safe. Patients treated with both Purastat and sucralfate had less bleeding, improved camera appearance and improved blood count. As this was a smaller tester study, we cannot say for certain whether Purastat is better than Sucralfate.
The research team will work with patients to develop a full study so that we can say for certain whether Purastat is a good treatment for bleeding from RP with a view to rolling out the treatment to everyone within 5-10 years.REC name
Wales REC 5
REC reference
21/WA/0122
Date of REC Opinion
20 Apr 2021
REC opinion
Favourable Opinion