Radiation ProctopathyPURASTATNCT04918758
Endoscopically-delivered Purastat to Treat Bleeding Caused by Radiation Proctopathy
A study testing Purastat Arm in people with Radiation Proctopathy, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Radiation Proctopathy
- What is being tested?
- Purastat Arm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Jul 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University NHS Foundation Trust
Manchester, M13 9WU
About this study
Official title: Endoscopically-delivered Purastat for the Treatment of Haemorrhagic Radiation Proctopathy: a Randomised Feasibility Study
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.
Read the 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
- Patients will attend for first sigmoidoscopy.
- The bleeding diary will be collected and EORTC-QLQ-C30/EQ5D-5L/baseline healthcare utilisation questionnaire (covering the preceding 6 months including details of iron use and blood transfusion) completed.
- Baseline bloods will be taken (FBC, ferritin and iron studies).
- Assessment will be made using a rectal bleeding score.
- Sigmoidoscopy: insertion to rectum only to assess extent and severity of radiation proctopathy. Endoscopic images will be taken including in retroflexion. Endoscopic grading will be completed by the endoscopist. Images will be graded independently by a second gastroenterologist and any differences discussed and reviewed by a third if required.
- Purastat group: 5mls Purastat will be delivered.
- Treatment as usual group: sucralfate enemas collected from pharmacy: 2g BD for 8 weeks to start that day.
- The bleeding diary will be completed for the subsequent 7 days prior to their sigmoidoscopy visit.
- Next sigmoidoscopy visit is booked
Week 3
•The 7-day bleeding diary will be completed.
Week 4
- Patients will attend for second sigmoidoscopy.
- The bleeding diaries will be collected and EORTC-QLQ-C30/EQ5D-5L/baseline healthcare utilisation questionnaire (covering the preceding 4 weeks including details of iron use and blood transfusion) completed.
- Assessment will be made using a rectal bleeding score.
- Sigmoidoscopy: insertion to rectum only to assess extent and severity of radiation proctopathy. Endoscopic images will be taken including in retroflexion. Endoscopic grading will be completed by the endoscopist. Images will be graded independently by a second gastroenterologist and any differences discussed and reviewed by a third if required.
- 5mls Purastat will be delivered to those randomised into the Purastat group.
- The bleeding diary will be completed for the subsequent 7 days prior to their sigmoidoscopy visit.
- Next sigmoidoscopy visit is booked
Week 7 •The 7-day bleeding diary will be completed.
Week 8
- Patients will attend for third sigmoidoscopy.
- The bleeding diaries will be collected and EORTC-QLQ-C30/EQ5D-5L/baseline healthcare utilisation questionnaire (covering the preceding 4 weeks including details of iron use and blood transfusion) completed.
- Bloods will be taken (FBC, ferritin and iron studies).
- Assessment will be made using a rectal bleeding score.
- Sigmoidoscopy: insertion to rectum only to assess extent and severity of radiation proctopathy. Endoscopic images will be taken including in retroflexion. Endoscopic grading will be completed by the endoscopist. Images will be graded independently by a second gastroenterologist and any differences discussed and reviewed by a third if required.
- 5mls Purastat will be delivered to those randomised into the Purastat group.
- The bleeding diary will be completed for the subsequent 7 days prior to their sigmoidoscopy visit.
- Next sigmoidoscopy visit is booked
Week 19
•The 7-day bleeding diary will be completed.
Week 20
- Patients will attend for fourth sigmoidoscopy.
- The bleeding diaries will be collected and EORTC-QLQ-C30/EQ5D-5L/baseline healthcare utilisation questionnaire (covering the preceding 12 weeks including details of iron use and blood transfusion) completed.
- Bloods will be taken (FBC, ferritin and iron studies).
- Assessment will be made using a rectal bleeding score.
- Sigmoidoscopy: insertion to rectum only to assess extent and severity of radiation proctopathy. Endoscopic images will be taken including in retroflexion. Endoscopic grading will be completed by the endoscopist. Images will be graded independently by a second gastroenterologist and any differences discussed and reviewed by a third if required.
- CSQ-8 completed prior to discharge from the endoscopy unit
- End of patient involvement
Purastat delivery technique
- Insertion of sigmoidoscope into rectum
- Purastat will be spread over the telangiectasia using the designated catheter
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
- Conditions
- Radiation Proctopathy
- Being tested
- Purastat Arm, Standard Care Arm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purastat ArmDevice
Also called PuraStat - 621-015
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.
Standard Care ArmDrug
Also called Sucralfate enemas - Enemas of sucralfate suspension (2 gm in 20 ml water)
Sucralfate enemas 2g twice daily for 8 weeks, this is standard care in patients with haemorrhagic radiation proctopathy in the short term
| Study group | Role | What they receive |
|---|---|---|
| Purastat Arm | Experimental | Purastat 5ml once monthly for 3 months Receives: Device: Purastat Arm |
| Standard Care Arm | Other | Sucralfate enemas 2g twice daily for 8 weeks Receives: Drug: Standard Care Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: through study completion, an average of 2 years
Secondary outcomes (6)
Usability of potential outcomes
Acceptability of questionnaires to participants (end of study research nurse contact)
Measured: through study completion, an average of 2 years
Usability of potential outcomes
the best outcome measures will be the most clinically meaningful with the least missing data which show sufficient variation between patients, including determining whether there are floor/ceiling effects, and within patients over time on statistical analysis.
Measured: through study completion, an average of 2 years
Usability of potential outcomes
The least data missing health economics outcome measures using validated questionnaires: EQ5D and health care utilisation questionnaire
Measured: through study completion, an average of 2 years
To determine whether necessary information can be gathered
Percentage of missing data
Measured: through study completion, an average of 2 years
To determine whether necessary information can be gathered
Attrition rates
Measured: through study completion, an average of 2 years
Sample size determination for a definitive multicentre trial to determine the clinical and cost effectiveness of endoscopically-delivered Purastat for the treatment of RP complicated by severe lower gastrointestinal bleeding.
Patient-reported bleeding episodes within the bleeding diary
Measured: Completed 7 days before, 7 days after and Weeks 0, 4, 8 and 20 sigmoidoscopies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start22 Jul 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation ProctopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Caroline Henson, Principal investigator, Manchester University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918758
- Sponsor's protocol ID
- B01152
- Other IDs
- 254308
- Acronym
- PURASTAT
- Status last verified
- Mar 2025
- First submitted
- 13 May 2021
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently no- This may be updated in the future
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopically-delivered Purastat for the Treatment of Haemorrhagic Radiation Proctopathy: a Randomised Feasibility Study
- ClinicalTrials.gov ID
- NCT04918758
- Acronym / sponsor ID
- PURASTAT / B01152
- Conditions
- Radiation Proctopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Patients will attend for first sigmoidoscopy.
- The bleeding diary will be collected and EORTC-QLQ-C30/EQ5D-5L/baseline healthcare utilisation questionnaire (covering the preceding 6 months including details of iron use and blood transfusion) completed.
- Baseline bloods will be taken (FBC, ferritin and iron studies).
- Assessment will be made using a rectal bleeding score.
- Sigmoidoscopy: insertion to rectum only to assess extent and severity of radiation proctopathy. Endoscopic images will be taken including in retroflexion. Endoscopic grading will be completed by the endoscopist. Images will be graded independently by a second gastroenterologist and any differences discussed and reviewed by a third if required.
- Purastat group: 5mls Purastat will be delivered.
- Treatment as usual group: sucralfate enemas collected from pharmacy: 2g BD for 8 weeks to start that day.
- The bleeding diary will be completed for the subsequent 7 days prior to their sigmoidoscopy visit.
- Next sigmoidoscopy visit is booked
Week 3
•The 7-day bleeding diary will be completed.
Week 4
- Patients will attend for second sigmoidoscopy.
- The bleeding diaries will be collected and EORTC-QLQ-C30/EQ5D-5L/baseline healthcare utilisation questionnaire (covering the preceding 4 weeks including details of iron use and blood transfusion) completed.
- Assessment will be made using a rectal bleeding score.
- Sigmoidoscopy: insertion to rectum only to assess extent and severity of radiation proctopathy. Endoscopic images will be taken including in retroflexion. Endoscopic grading will be completed by the endoscopist. Images will be graded independently by a second gastroenterologist and any differences discussed and reviewed by a third if required.
- 5mls Purastat will be delivered to those randomised into the Purastat group.
- The bleeding diary will be completed for the subsequent 7 days prior to their sigmoidoscopy visit.
- Next sigmoidoscopy visit is booked
Week 7 •The 7-day bleeding diary will be completed.
Week 8
- Patients will attend for third sigmoidoscopy.
- The bleeding diaries will be collected and EORTC-QLQ-C30/EQ5D-5L/baseline healthcare utilisation questionnaire (covering the preceding 4 weeks including details of iron use and blood transfusion) completed.
- Bloods will be taken (FBC, ferritin and iron studies).
- Assessment will be made using a rectal bleeding score.
- Sigmoidoscopy: insertion to rectum only to assess extent and severity of radiation proctopathy. Endoscopic images will be taken including in retroflexion. Endoscopic grading will be completed by the endoscopist. Images will be graded independently by a second gastroenterologist and any differences discussed and reviewed by a third if required.
- 5mls Purastat will be delivered to those randomised into the Purastat group.
- The bleeding diary will be completed for the subsequent 7 days prior to their sigmoidoscopy visit.
- Next sigmoidoscopy visit is booked
Week 19
•The 7-day bleeding diary will be completed.
Week 20
- Patients will attend for fourth sigmoidoscopy.
- The bleeding diaries will be collected and EORTC-QLQ-C30/EQ5D-5L/baseline healthcare utilisation questionnaire (covering the preceding 12 weeks including details of iron use and blood transfusion) completed.
- Bloods will be taken (FBC, ferritin and iron studies).
- Assessment will be made using a rectal bleeding score.
- Sigmoidoscopy: insertion to rectum only to assess extent and severity of radiation proctopathy. Endoscopic images will be taken including in retroflexion. Endoscopic grading will be completed by the endoscopist. Images will be graded independently by a second gastroenterologist and any differences discussed and reviewed by a third if required.
- CSQ-8 completed prior to discharge from the endoscopy unit
- End of patient involvement
Purastat delivery technique
- Insertion of sigmoidoscope into rectum
- Purastat will be spread over the telangiectasia using the designated catheter
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Purastat Arm | Experimental | Device: Purastat ArmPurastat 5ml once monthly for 3 months |
| Standard Care Arm | Other | Drug: Standard Care ArmSucralfate enemas 2g twice daily for 8 weeks |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Purastat ArmAlso: PuraStat - 621-015Generic 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. | Device | Purastat Arm |
| Standard Care ArmAlso: Sucralfate enemas - Enemas of sucralfate suspension (2 gm in 20 ml water)Sucralfate enemas 2g twice daily for 8 weeks, this is standard care in patients with haemorrhagic radiation proctopathy in the short term | Drug | Standard Care Arm |
Primary outcome
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
Time frame: through study completion, an average of 2 years
Participants will be asked to describe their experience of the study process using a validated questionnaire (CSQ-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
Time frame: through study completion, an average of 2 years
Participants will be asked to describe their reason for attrition verbally (end of study research nurse contact)
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
Time frame: through study completion, an average of 2 years
Attrition Rates to both study arms
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
Time frame: through study completion, an average of 2 years
rate of recruitment
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
Time frame: through study completion, an average of 2 years
Participants will be asked to describe their acceptability of the randomisation process verbally (end of study research nurse contact)
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
Time frame: through study completion, an average of 2 years
Participants will be asked to describe their acceptability of the recruitment process verbally (end of study research nurse contact)
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
Time frame: through study completion, an average of 2 years
Participants will be asked to describe their acceptability of the intervention on a validated questionnaire (CSQ-8)
Safety of endoscopically-delivered Purastat for the treatment of RP complicated by severe lower gastrointestinal bleeding.
Time frame: through study completion, an average of 2 years
Incidents of SAEs and AEs
6 secondary outcomes
Usability of potential outcomes
Time frame: through study completion, an average of 2 years
Usability of potential outcomes
Time frame: through study completion, an average of 2 years
Usability of potential outcomes
Time frame: through study completion, an average of 2 years
To determine whether necessary information can be gathered
Time frame: through study completion, an average of 2 years
To determine whether necessary information can be gathered
Time frame: through study completion, an average of 2 years
Sample size determination for a definitive multicentre trial to determine the clinical and cost effectiveness of endoscopically-delivered Purastat for the treatment of RP complicated by severe lower gastrointestinal bleeding.
Time frame: Completed 7 days before, 7 days after and Weeks 0, 4, 8 and 20 sigmoidoscopies
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No. Currently no- This may be updated in the future
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Henson principal investigator
Manchester University NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Purastat Arm in people with Radiation Proctopathy, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: through study completion, an average of 2 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.