A Evaluation of the Utilisation, Effectiveness and Safety of Purastat® in the Management of Gastrointestinal Bleeding
- Conditions
- Gastrointestinal Bleeding
- Registration Number
- NCT03983707
- Lead Sponsor
- Portsmouth Hospitals NHS Trust
- Brief Summary
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
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 379
- Active GI bleeding or high risk for active GI bleeding
- Variceal or arterial bleeding
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effectiveness of Purastat® in controlling bleeding Day 28 (delayed bleeding) Number (and proportion) of bleeds successfully controlled by application of Purastat®
- Secondary Outcome Measures
Name Time Method Effectiveness of Purastat® in preventing delayed bleeding Day 28 Delayed bleeding rate
Technical feasibility of use of Purastat® Day 1 (periprocedural) Any difficulty in Purastat application (yes/no)
Patterns of Purastat® usage 24 months Purastat® utilisation (including indications)
Unexpected reactions that may be attributed to the use of Purastat® Day 28 Occurrence of Suspected Unexpected Serious Adverse Reactions (SUSAR) related to Purastat®
Trial Locations
- Locations (1)
Queen Alexandra Hospital
🇬🇧Portsmouth, Hampshire, United Kingdom