Endoscopically-delivered Purastat to Treat Bleeding Caused by Radiation Proctopathy
Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
Manchester University NHS Foundation Trust
Collaborator:
National Institute for Health Research, United Kingdom