Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03983707
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Collaborators:
3-D Matrix Europe SAS
Gloucestershire Hospitals NHS Foundation Trust
Wrightington, Wigan & Leigh NHS Foundation Trust
Addenbrookes Hospital, Cambridge
University Hospital Birmingham NHS Foundation Trust
Nottingham University Hospitals NHS Trust
Basildon & Thurrock University Hospitals NHS Trust
East Kent Hospitals University NHS Foundation Trust
University College London Hospitals
North Tees and Hartlepool NHS Foundation Trust
Royal Sussex County Hospital, Brighton
King's College Hospital, London
St Mary's Hospital, Imperial College Healthcare NHS Trust, London
Heartlands Hospital, Heart of England NHS Foundation Trust
Leeds Teaching Hospitals NHS Trust
Royal London Hospital, Barts Health NHS Trust
St Mark's Hospital, Harrow
Manchester University NHS Foundation Trust
Oxford University Hospitals NHS Trust
Glasgow Royal Infirmary
Information provided by (Responsible Party):
Portsmouth Hospitals NHS Trust

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


Condition or disease Intervention/treatment
Gastrointestinal Bleeding 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

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 28 Days
Official Title: A Multicentre Prospective Observational Study to Evaluate the Utilisation, Effectiveness and Safety of Purastat® in the Management of Gastrointestinal Bleeding
Actual Study Start Date : January 23, 2019
Estimated Primary Completion Date : January 23, 2021
Estimated Study Completion Date : February 23, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Purastat®
    Use of Purastat®


Primary Outcome Measures :
  1. Effectiveness of Purastat® in controlling bleeding [ Time Frame: Day 1 (intraprocedural bleeding) ]
    Number (and proportion) of bleeds successfully controlled by application of Purastat®

  2. Effectiveness of Purastat® in controlling bleeding [ Time Frame: Day 28 (delayed bleeding) ]
    Number (and proportion) of bleeds successfully controlled by application of Purastat®


Secondary Outcome Measures :
  1. Effectiveness of Purastat® in preventing delayed bleeding [ Time Frame: Day 28 ]
    Delayed bleeding rate

  2. Technical feasibility of use of Purastat® [ Time Frame: Day 1 (periprocedural) ]
    Any difficulty in Purastat application (yes/no)

  3. Unexpected reactions that may be attributed to the use of Purastat® [ Time Frame: Day 28 ]
    Occurrence of Suspected Unexpected Serious Adverse Reactions (SUSAR) related to Purastat®

  4. Patterns of Purastat® usage [ Time Frame: 24 months ]
    Purastat® utilisation (including indications)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
Criteria

Inclusion Criteria:

  • Active GI bleeding or high risk for active GI bleeding

Exclusion Criteria:

  • Variceal or arterial bleeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983707


Contacts
Layout table for location contacts
Contact: Pradeep Bhandari 023 9228 6000 ext 5852 pradeep.bhandari@porthosp.nhs.uk
Contact: Laura Marshall 023 9228 6000 ext 5455 Laura.Marshall2@porthosp.nhs.uk

Locations
Layout table for location information
United Kingdom
Queen Alexandra Hospital Recruiting
Portsmouth, Hampshire, United Kingdom, PO6 3LY
Contact: Alice Mortlock    023 9228 6000 ext 4042    alice.mortlock@porthosp.nhs.uk   
Contact: Laura Marshall    02392 286000 ext 5455    Laura.Marshall2@porthosp.nhs.uk   
Sponsors and Collaborators
Portsmouth Hospitals NHS Trust
3-D Matrix Europe SAS
Gloucestershire Hospitals NHS Foundation Trust
Wrightington, Wigan & Leigh NHS Foundation Trust
Addenbrookes Hospital, Cambridge
University Hospital Birmingham NHS Foundation Trust
Nottingham University Hospitals NHS Trust
Basildon & Thurrock University Hospitals NHS Trust
East Kent Hospitals University NHS Foundation Trust
University College London Hospitals
North Tees and Hartlepool NHS Foundation Trust
Royal Sussex County Hospital, Brighton
King's College Hospital, London
St Mary's Hospital, Imperial College Healthcare NHS Trust, London
Heartlands Hospital, Heart of England NHS Foundation Trust
Leeds Teaching Hospitals NHS Trust
Royal London Hospital, Barts Health NHS Trust
St Mark's Hospital, Harrow
Manchester University NHS Foundation Trust
Oxford University Hospitals NHS Trust
Glasgow Royal Infirmary
Investigators
Layout table for investigator information
Principal Investigator: Pradeep Bhandari Portsmouth Hospitals NHS Trust

Layout table for additonal information
Responsible Party: Portsmouth Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03983707    
Other Study ID Numbers: PHT/2018/39
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Portsmouth Hospitals NHS Trust:
Purastat
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases