A Evaluation of the Utilisation, Effectiveness and Safety of Purastat® in the Management of Gastrointestinal Bleeding
NCT ID: NCT03983707
Last Updated: 2025-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
379 participants
OBSERVATIONAL
2019-01-23
2021-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy of a Novel Hemostatic Powder in GI Bleeding
NCT02595853
Analysis of Blood Metabolomics to Identify Potential Biomarkers of Gastrointestinal Bleeding
NCT05547360
PillSense System for Detecting UGI Bleed
NCT05385224
To Compare a Hemostatic Powder TC-325 and Standard Treatment in the Control of Acute Upper Gastrointestinal Bleeding From Nonvariceal Causes
NCT02534571
The Effect of Chemoradiotherapy on Gastric Perfusion in Patients With Gastric Cancer.
NCT05354856
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Purastat®
Use of Purastat®
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
3-D Matrix Europe SAS
INDUSTRY
Gloucestershire Hospitals NHS Foundation Trust
OTHER
Cambridge University Hospitals NHS Foundation Trust
OTHER
University Hospital Birmingham NHS Foundation Trust
OTHER
Nottingham University Hospitals NHS Trust
OTHER
Mid and South Essex NHS Foundation Trust
OTHER
East Kent Hospitals University NHS Foundation Trust
OTHER_GOV
University College London Hospitals
OTHER
North Tees and Hartlepool NHS Foundation Trust
OTHER
Brighton and Sussex University Hospitals NHS Trust
OTHER
King's College Hospital NHS Trust
OTHER
Imperial College Healthcare NHS Trust
OTHER
Heart of England NHS Foundation Trust
UNKNOWN
The Leeds Teaching Hospitals NHS Trust
OTHER
Barts & The London NHS Trust
OTHER
London North West Healthcare NHS Trust
OTHER
Manchester University NHS Foundation Trust
OTHER_GOV
Oxford University Hospitals NHS Trust
OTHER
Glasgow Royal Infirmary
OTHER
Guy's and St Thomas' NHS Foundation Trust
OTHER
Northern Care Alliance NHS Foundation Trust
OTHER
University Hospital Southampton NHS Foundation Trust
OTHER
Portsmouth Hospitals NHS Trust
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pradeep Bhandari
Role: PRINCIPAL_INVESTIGATOR
Portsmouth Hospitals NHS Trust
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Queen Alexandra Hospital
Portsmouth, Hampshire, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PHT/2018/39
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.