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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Radiation Proctopathy | Device: Purastat Arm Drug: Standard Care Arm | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | 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 |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Endoscopically-delivered Purastat for the Treatment of Haemorrhagic Radiation Proctopathy: a Randomised Feasibility Study |
Actual Study Start Date : | July 22, 2021 |
Estimated Primary Completion Date : | December 31, 2022 |
Estimated Study Completion Date : | December 31, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: Purastat Arm
Purastat 5ml once monthly for 3 months
|
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:
Other Name: PuraStat - 621-015
|
Standard Care Arm
Sucralfate enemas 2g twice daily for 8 weeks
|
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
Other Name: Sucralfate enemas - Enemas of sucralfate suspension (2 gm in 20 ml water)
|
Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion criteria
Contact: Caroline Henson | 0161 291 3525 | caroline.henson@mft.nhs.uk | |
Contact: Hayley Brooks | 0161 291 2433 | hayley.brooks@mft.nhs.uk |
United Kingdom | |
Manchester University NHS Foundation Trust | Recruiting |
Manchester, United Kingdom, M13 9WU | |
Contact: Hayley Brooks hayley.brooks@mft.nhs.uk |
Principal Investigator: | Caroline Henson | Manchester University NHS Foundation Trust |
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | May 13, 2021 | ||||||||
First Posted Date ICMJE | June 9, 2021 | ||||||||
Last Update Posted Date | September 21, 2021 | ||||||||
Actual Study Start Date ICMJE | July 22, 2021 | ||||||||
Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
|
||||||||
Original Primary Outcome Measures ICMJE |
|
||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
|
||||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Endoscopically-delivered Purastat to Treat Bleeding Caused by Radiation Proctopathy | ||||||||
Official Title ICMJE | Endoscopically-delivered Purastat for the Treatment of Haemorrhagic Radiation Proctopathy: a Randomised Feasibility Study | ||||||||
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. |
||||||||
Detailed Description |
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. Assessment Tools 1.Demographic data 2.7 day patient-reported rectal bleeding diary 3.Rectal bleeding score 4.Endoscopic grading: Zinicola score, rectal telangiectasia density score 5.Bloods: Haemoglobin concentration, ferritin 6.Blood transfusion requirement 7.Iron replacement requirement 8.Quality of life (EQ5D 5L) 9. Healthcare use including GP visits, hospital visit, A&E attendences, day case hospital visits, hospital admissions, blood transfusion and iron use. The study duration will be 20 weeks (+/- 2 weeks). The timing of assessments will be baseline following consent (week 0); week 4 (+/- 1 week); week 8 (+/- 1 week); and week 20 (+/- 2 weeks). Patients will be screened at their clinic appointment by study doctor. If they meet eligibility criteria, then verbal consent will be taken from the participant for the research nurse to contact them via telephone to discuss the study further. If the participant is happy to take part in the study following discussion with the research nurse then a follow-up telephone call will be arranged with study doctor for the participant to confirm happy to proceed and ask any further questions. An invitation letter plus participant information sheet and informed consent form will be either sent to the participant via post or email. There are then 2 options for taking informed consent - either a telephone informed consent visit with return of informed consent to investigator site OR a face to face informed consent visit with respective study investigator and research nurse. Demographic data plus details of cancer treatment, site, comorbidities, previous treatment for radiation proctopathy will be obtained. Participants will be allocated a study number and anonymised. They will then be 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. An independent randomisation schedule will be generated for each of the Hospitals. Prescriptions for sucralfate 2g BD for 2 months will be issued to those randomised to treatment as usual for collection at first sigmoidoscopy appointment. The research nurse will contact the participant to inform them of the arm they have been randomised to, confirm their baseline sigmoidoscopy visit date and ensure that they start completing their bleeding diary/healthcare utilisation starting 7 days before their baseline visit. Demographic data plus details of cancer treatment, site, comorbidities, previous treatment for radiation proctopathy will be obtained. Patients will be allocated a study number and anonymised. They will then be 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. An independent randomisation schedule will be generated for each of the Hospitals. Prescriptions for sucralfate 2g BD for 2 months will be issued to those randomised to treatment as usual for collection at first sigmoidoscopy appointment. Week 0 -1 •The 7-day bleeding diary will be completed. Week 0
Week 3 •The 7-day bleeding diary will be completed. Week 4
Week 7 •The 7-day bleeding diary will be completed. Week 8
Week 19 •The 7-day bleeding diary will be completed. Week 20
Purastat delivery technique
On discharge from the endoscopy unit all patients will be given bleeding diaries and study team will arrange the next sigmoidoscopy appointment. Patients will be contacted by the research nurse via telephone at weeks 3, 7 and 19 to prompt completion of bleeding diary. Individuals who dropped out of the study will be contacted by week 28 by the research nurse |
||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: 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 Primary Purpose: Treatment |
||||||||
Condition ICMJE | Radiation Proctopathy | ||||||||
Intervention ICMJE |
|
||||||||
Study Arms ICMJE |
|
||||||||
Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
80 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 31, 2022 | ||||||||
Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion criteria
Exclusion criteria
|
||||||||
Sex/Gender ICMJE |
|
||||||||
Ages ICMJE | 16 Years and older (Child, Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
|
||||||||
Listed Location Countries ICMJE | United Kingdom | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04918758 | ||||||||
Other Study ID Numbers ICMJE | B01152 254308 ( Other Identifier: IRAS ) |
||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
|
||||||||
IPD Sharing Statement ICMJE |
|
||||||||
Responsible Party | Manchester University NHS Foundation Trust | ||||||||
Study Sponsor ICMJE | Manchester University NHS Foundation Trust | ||||||||
Collaborators ICMJE | National Institute for Health Research, United Kingdom | ||||||||
Investigators ICMJE |
|
||||||||
PRS Account | Manchester University NHS Foundation Trust | ||||||||
Verification Date | September 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |