Endoscopically-delivered Purastat to Treat Bleeding Caused by Radiation Proctopathy

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.

Conditions

• Radiation Proctopathy

Interventions

DEVICE

Purastat Arm

Generic name of device and principal intended use(s): Still PuraStat from a CE mark perspective. PuraStat is an aqueous self-assembling peptide solution of 2.5% concentration RADA16 Indication for use: PuraStat is indicated for haemostasis in the following situations encountered during surgery, when haemostasis by ligation or standard means is insufficient or impractical: * Bleeding from small blood vessels and oozing from capillaries of the parenchyma of solid organs. Oozing from vascular anastomoses * Bleeding from small blood vessels and oozing from capillaries of the GI tract following surgical procedures * Reduction of delayed bleeding following gastrointestinal endoscopic submucosal dissection (ESD) procedures in the colon.

DRUG

Standard Care Arm

Sucralfate enemas 2g twice daily for 8 weeks, this is standard care in patients with haemorrhagic radiation proctopathy in the short term

Sponsors & Collaborators

• National Institute for Health Research, United Kingdom

  collaborator OTHER_GOV

• Manchester University NHS Foundation Trust

  lead OTHER_GOV

Principal Investigators

• Caroline Henson · Manchester University NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-07-22

Primary Completion

2024-12-31

Completion

2024-12-31

Countries

• United Kingdom

Study Locations