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

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

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

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Bleeding; Delayed Bleeding
• Intervention / Treatment: Device: Purastat®

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

• Study Type: Observational
• Enrollment (Actual): 379

Contacts and Locations

Study Locations

• United Kingdom
  • Hampshire
    • Portsmouth, Hampshire, United Kingdom, PO6 3LY
      • Queen Alexandra Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults with GI bleeding or a high risk of bleeding during endoscopic procedures where Purastat® is used

Description

Inclusion Criteria:

• Active GI bleeding or high risk for active GI bleeding

Exclusion Criteria:

• Variceal or arterial bleeding

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Portsmouth Hospitals NHS Trust
• Collaborators: King's College Hospital NHS Trust; University College London Hospitals; Northern Care Alliance NHS Foundation Trust; The Leeds Teaching Hospitals NHS Trust; Cambridge University Hospitals NHS Foundation Trust; Nottingham University Hospitals NHS Trust; Guy's and St Thomas' NHS Foundation Trust; East Kent Hospitals University NHS Foundation Trust; Barts & The London NHS Trust; University Hospital Birmingham NHS Foundation Trust; Mid and South Essex NHS Foundation Trust; Manchester University NHS Foundation Trust; University Hospital Southampton NHS Foundation Trust; Brighton and Sussex University Hospitals NHS Trust; Oxford University Hospitals NHS Trust; Imperial College Healthcare NHS Trust; London North West Healthcare NHS Trust; North Tees and Hartlepool NHS Foundation Trust; Heart of England NHS Foundation Trust; Gloucestershire Hospitals NHS Foundation Trust; Glasgow Royal Infirmary; 3-D Matrix Europe SAS
• Investigators: Principal Investigator: Pradeep Bhandari, Portsmouth Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2019
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (Actual): June 12, 2019

Study Record Updates

• Last Update Posted (Actual): May 31, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Purastat
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: PHT/2018/39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No