Endoscopically-delivered Purastat to Treat Bleeding Caused by Radiation Proctopathy

NCT04918758 | Completed DMC

• 2 other identifiers: B01152254308
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (8)

• Feasibility to deliver a full randomised controlled trial to determine if Purastat reduces lower gastrointestinal bleeding in patients with haemorrhagic radiation proctopathy in the short term compared to standard treatment with sucralfate enemas

  Participants will be asked to describe their experience of the study process using a validated questionnaire (CSQ-8)

  through study completion, an average of 2 years

• Feasibility to deliver a full randomised controlled trial to determine if Purastat reduces lower gastrointestinal bleeding in patients with haemorrhagic radiation proctopathy in the short term compared to standard treatment with sucralfate enemas

  Participants will be asked to describe their reason for attrition verbally (end of study research nurse contact)

  through study completion, an average of 2 years

• Feasibility to deliver a full randomised controlled trial to determine if Purastat reduces lower gastrointestinal bleeding in patients with haemorrhagic radiation proctopathy in the short term compared to standard treatment with sucralfate enemas

  Attrition Rates to both study arms

  through study completion, an average of 2 years

• Feasibility to deliver a full randomised controlled trial to determine if Purastat reduces lower gastrointestinal bleeding in patients with haemorrhagic radiation proctopathy in the short term compared to standard treatment with sucralfate enemas

  rate of recruitment

  through study completion, an average of 2 years

• Feasibility to deliver a full randomised controlled trial to determine if Purastat reduces lower gastrointestinal bleeding in patients with haemorrhagic radiation proctopathy in the short term compared to standard treatment with sucralfate enemas

  Participants will be asked to describe their acceptability of the randomisation process verbally (end of study research nurse contact)

  through study completion, an average of 2 years

• Feasibility to deliver a full randomised controlled trial to determine if Purastat reduces lower gastrointestinal bleeding in patients with haemorrhagic radiation proctopathy in the short term compared to standard treatment with sucralfate enemas

  Participants will be asked to describe their acceptability of the recruitment process verbally (end of study research nurse contact)

  through study completion, an average of 2 years

• Feasibility to deliver a full randomised controlled trial to determine if Purastat reduces lower gastrointestinal bleeding in patients with haemorrhagic radiation proctopathy in the short term compared to standard treatment with sucralfate enemas

  Participants will be asked to describe their acceptability of the intervention on a validated questionnaire (CSQ-8)

  through study completion, an average of 2 years

• Safety of endoscopically-delivered Purastat for the treatment of RP complicated by severe lower gastrointestinal bleeding.

  Incidents of SAEs and AEs

  through study completion, an average of 2 years

Secondary Outcomes (6)

• Usability of potential outcomes

  through study completion, an average of 2 years

• Usability of potential outcomes

  through study completion, an average of 2 years

• Usability of potential outcomes

  through study completion, an average of 2 years

• To determine whether necessary information can be gathered

  through study completion, an average of 2 years

• To determine whether necessary information can be gathered

  through study completion, an average of 2 years

Study Arms (2)

Purastat Arm

EXPERIMENTAL

Purastat 5ml once monthly for 3 months

Device: Purastat Arm

Standard Care Arm

OTHER

Sucralfate enemas 2g twice daily for 8 weeks

Drug: Standard Care Arm

Interventions

Purastat Arm DEVICE

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.

Also known as: PuraStat - 621-015

Purastat Arm

Standard Care Arm DRUG

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

Also known as: Sucralfate enemas - Enemas of sucralfate suspension (2 gm in 20 ml water)

Standard Care Arm

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>16 years old
• Pelvic radiotherapy completed \>6 months previously
• Endoscopically confirmed diagnosis of radiation proctopathy on lower GI endoscopy (sigmoidoscopy or colonoscopy) as characterised by the typical endoscopic appearances of superficial friable serpiginous telangiectasia, mucosal pallor and oedema
• Significant rectal bleeding (\>weekly passage of blood into toilet bowl +/- anaemia which is ongoing for at least 3 months)
• Full colonic evaluation (colonoscopy or CT colonogram) to exclude other causes for rectal bleeding
• Capable of providing informed consent to a participant information sheet written in English

You may not qualify if:

• Age \<16 years
• Unable to have full colonic evaluation to exclude other causes of rectal bleeding
• Other untreated cause for rectal bleeding
• Previous Purastat treatment for RP
• Previous Sucralfate treatment for RP

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, M13 9WU, United Kingdom

Location

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Caroline Henson

  Manchester University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomised to Purastat or treatment as usual (sucralfate enemas) using block sizes of 4 or 6, with block size itself determined at random. Randomisation will be stratified by Hospital Post-Market Phase

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: June 9, 2021
• Study Start: July 22, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)