A Evaluation of the Utilisation, Effectiveness and Safety of Purastat® in the Management of Gastrointestinal Bleeding

Study Overview
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Brief Summary
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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
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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

Official Title
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A Multicentre Prospective Observational Study to Evaluate the Utilisation, Effectiveness and Safety of Purastat® in the Management of Gastrointestinal Bleeding

Conditions
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Gastrointestinal Bleeding

Intervention / Treatment
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* Device: Purastat®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active GI bleeding or high risk for active GI bleeding Exclusion Criteria: Variceal or arterial bleeding
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Purastat®|Use of Purastat®|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of Purastat® in controlling bleeding | Number (and proportion) of bleeds successfully controlled by application of Purastat® | Day 1 (intraprocedural bleeding) | 
| Effectiveness of Purastat® in controlling bleeding | Number (and proportion) of bleeds successfully controlled by application of Purastat® | Day 28 (delayed bleeding) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of Purastat® in preventing delayed bleeding | Delayed bleeding rate | Day 28 | 
| Technical feasibility of use of Purastat® | Any difficulty in Purastat application (yes/no) | Day 1 (periprocedural) | 
| Unexpected reactions that may be attributed to the use of Purastat® | Occurrence of Suspected Unexpected Serious Adverse Reactions (SUSAR) related to Purastat® | Day 28 | 
| Patterns of Purastat® usage | Purastat® utilisation (including indications) | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Purastat