Endoscopically-delivered Purastat for the Treatment of Haemorrhagic Radiation Proctopathy: a Randomised Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Safety of endoscopically-delivered Purastat for the treatment of RP complicated by severe lower gastrointestinal bleeding.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Purastat Arm
Purastat 5ml once monthly for 3 months
干预措施: Purastat Arm (Device)
Standard Care Arm
Sucralfate enemas 2g twice daily for 8 weeks
干预措施: Standard Care Arm (Drug)
结局指标
主要结局
Safety of endoscopically-delivered Purastat for the treatment of RP complicated by severe lower gastrointestinal bleeding.
时间窗: through study completion, an average of 2 years
Incidents of SAEs and AEs
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
时间窗: 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)
次要结局
- To determine whether necessary information can be gathered(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.(Completed 7 days before, 7 days after and Weeks 0, 4, 8 and 20 sigmoidoscopies)
- Usability of potential outcomes(through study completion, an average of 2 years)