A Multicentre Prospective Observational Study to Evaluate the Utilisation, Effectiveness and Safety of Purastat® in the Management of Gastrointestinal Bleeding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 379
- 试验地点
- 1
- 主要终点
- Effectiveness of Purastat® in controlling bleeding
研究概览
简要总结
Problem statement
GI bleeding can arise from peptic ulcers, malignancy, angiodysplasia or during endoscopic resection procedures such as endoscopic mucosal resection and endoscopic submucosal dissection. This is conventionally treated using heat therapy or clips. These methods carry a risk of thermal injury or perforation. Purastat® is a novel synthetic haemostatic agent licensed as a CE marked device for use in GI bleeding. It also has the potential to enhance endoscopic mucosal wound healing and may play a role in preventing delayed bleeding. However, clinical data on its effectiveness in the GI tract is limited. Prospective data collection on the range of indications for Purastat® use and outcome data related to clinical effectiveness, safety and feasibility is required to inform clinicians about the best use for this agent.
Research question / hypothesis
To establish a prospective registry study to collect outcome data related to the use of Purastat® for the clinical management of GI bleeding or prevention of bleeding
Study Design
Prospective multicentre cohort study
Study Participants
Adults with GI bleeding or a high risk of bleeding during endoscopic procedures where Purastat® has been used
Follow-up duration
All patients will be followed up as per standard clinical care where applicable
Planned Study Period
2 years
Primary Objective
To assess the effectiveness of Purastat® as a haemostatic agent when used in the treatment of GI bleeding
Secondary Objectives
To assess the incidence of delayed bleeding after use of Purastat®, defined as procedure related bleeding up to 28 days following endoscopic resection To evaluate the rate of rebleeding following primary application of Purastat® for haemostasis To assess the technical feasibility and ease of use of Purastat® when used in the treatment or prevention of GI bleeding To monitor any unexpected reactions that may be attributed to the use of Purastat® To describe utilisation patterns in different clinical centres (indication, patient characteristics etc) and to observe trends in utilisation over time
详细描述
Problem statement
GI bleeding can arise from peptic ulcers, malignancy, angiodysplasia or during endoscopic resection procedures such as endoscopic mucosal resection and endoscopic submucosal dissection. This is conventionally treated using heat therapy or clips. These methods carry a risk of thermal injury or perforation. Purastat® is a novel synthetic haemostatic agent licensed as a CE marked device for use in GI bleeding. It also has the potential to enhance endoscopic mucosal wound healing and may play a role in preventing delayed bleeding. However, clinical data on its effectiveness in the GI tract is limited. Prospective data collection on the range of indications for Purastat® use and outcome data related to clinical effectiveness, safety and feasibility is required to inform clinicians about the best use for this agent.
Research question / hypothesis
To establish a prospective registry study to collect outcome data related to the use of Purastat® for the clinical management of GI bleeding or prevention of bleeding
Study Design
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active GI bleeding or high risk for active GI bleeding
排除标准
- •Variceal or arterial bleeding
结局指标
主要结局
Effectiveness of Purastat® in controlling bleeding
时间窗: Day 28 (delayed bleeding)
Number (and proportion) of bleeds successfully controlled by application of Purastat®
次要结局
- Effectiveness of Purastat® in preventing delayed bleeding(Day 28)
- Technical feasibility of use of Purastat®(Day 1 (periprocedural))
- Patterns of Purastat® usage(24 months)
- Unexpected reactions that may be attributed to the use of Purastat®(Day 28)