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

Gastrointestinal Bleeding Clinical Trial

— POPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03983707
• Other study ID #: PHT/2018/39
• Status: Completed
• Start date: January 23, 2019
• Est. completion date: October 31, 2021

Study information

• Verified date: September 2022
• Source: Portsmouth Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 379
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Active GI bleeding or high risk for active GI bleeding

Exclusion Criteria:

• Variceal or arterial bleeding

Related Conditions & MeSH terms

• Gastrointestinal Bleeding
• Gastrointestinal Hemorrhage
• Hemorrhage

Intervention

Device:
• Purastat®
Use of Purastat®

Locations

Country	Name	City	State
United Kingdom	Queen Alexandra Hospital	Portsmouth	Hampshire

Sponsors (23)

Lead Sponsor

Collaborator

Portsmouth Hospitals NHS Trust

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

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of Purastat® in controlling bleeding	Number (and proportion) of bleeds successfully controlled by application of Purastat®	Day 1 (intraprocedural bleeding)
Primary	Effectiveness of Purastat® in controlling bleeding	Number (and proportion) of bleeds successfully controlled by application of Purastat®	Day 28 (delayed bleeding)
Secondary	Effectiveness of Purastat® in preventing delayed bleeding	Delayed bleeding rate	Day 28
Secondary	Technical feasibility of use of Purastat®	Any difficulty in Purastat application (yes/no)	Day 1 (periprocedural)
Secondary	Unexpected reactions that may be attributed to the use of Purastat®	Occurrence of Suspected Unexpected Serious Adverse Reactions (SUSAR) related to Purastat®	Day 28
Secondary	Patterns of Purastat® usage	Purastat® utilisation (including indications)	24 months