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

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

Interventions

DEVICE

Purastat®

Use of Purastat®

Sponsors & Collaborators

• 3-D Matrix Europe SAS

  collaborator INDUSTRY

• Gloucestershire Hospitals NHS Foundation Trust

  collaborator OTHER

• Cambridge University Hospitals NHS Foundation Trust

  collaborator OTHER

• University Hospital Birmingham NHS Foundation Trust

  collaborator OTHER

• Nottingham University Hospitals NHS Trust

  collaborator OTHER

• Mid and South Essex NHS Foundation Trust

  collaborator OTHER

• East Kent Hospitals University NHS Foundation Trust

  collaborator OTHER_GOV

• University College London Hospitals

  collaborator OTHER

• North Tees and Hartlepool NHS Foundation Trust

  collaborator OTHER

• Brighton and Sussex University Hospitals NHS Trust

  collaborator OTHER

• King's College Hospital NHS Trust

  collaborator OTHER

• Imperial College Healthcare NHS Trust

  collaborator OTHER

• Heart of England NHS Foundation Trust

  collaborator UNKNOWN

• The Leeds Teaching Hospitals NHS Trust

  collaborator OTHER

• Barts & The London NHS Trust

  collaborator OTHER

• London North West Healthcare NHS Trust

  collaborator OTHER

• Manchester University NHS Foundation Trust

  collaborator OTHER_GOV

• Oxford University Hospitals NHS Trust

  collaborator OTHER

• Glasgow Royal Infirmary

  collaborator OTHER

• Guy's and St Thomas' NHS Foundation Trust

  collaborator OTHER

• Northern Care Alliance NHS Foundation Trust

  collaborator OTHER

• University Hospital Southampton NHS Foundation Trust

  collaborator OTHER

• Portsmouth Hospitals NHS Trust

  lead OTHER_GOV

Principal Investigators

• Pradeep Bhandari · Portsmouth Hospitals NHS Trust

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-23

Primary Completion

2021-10-31

Completion

2021-10-31

Countries

• United Kingdom

Study Locations