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

NCT03983707 | Completed DMC

• 1 other identifier: PHT/2018/39
• Study Type: observational
• Target: 379
• Locations: 1 country
• Sites: 1

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

Conditions

Gastrointestinal Bleeding; Delayed Bleeding

Keywords

Purastat

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Effectiveness of Purastat® in preventing delayed bleeding

  Day 28

• Technical feasibility of use of Purastat®

  Day 1 (periprocedural)

• Unexpected reactions that may be attributed to the use of Purastat®

  Day 28

• Patterns of Purastat® usage

  24 months

Interventions

Purastat® DEVICE

Use of Purastat®

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Active GI bleeding or high risk for active GI bleeding

You may not qualify if:

• Variceal or arterial bleeding

Sponsors & Collaborators

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

Study Sites (1)

Queen Alexandra Hospital

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pradeep Bhandari

  Portsmouth Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: June 12, 2019
• Study Start: January 23, 2019
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: May 31, 2025

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)