NCT03983707

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 379 (actual)
• Sponsor: Portsmouth Hospitals NHS Trust · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Gastrointestinal Bleeding
• Delayed Bleeding

Interventions

Type	Name	Description
DEVICE	Purastat®	Use of Purastat®

Timeline

• Start date: 2019-01-23
• Primary completion: 2021-10-31
• Completion: 2021-10-31
• First posted: 2019-06-12
• Last updated: 2025-05-31

Locations

1 site across 1 country: United Kingdom