Efficacy of a Novel Hemostatic Powder in GI Bleeding (GRAPHE)

September 8, 2021 updated by: Nantes University Hospital

A Novel Hemostatic Powder for the Endoscopic Treatment of Gastrointestinal Bleeding: Evaluation of Efficacy, Feasibility and Rebleeding Predictive Factors Results From a Multicenter Prospective Study Performed in Routine Practice

Hemospray™ is a new endoscopic hemostatic powder. Aims of this multicenter prospective study is to determine effectiveness of Hemospray™ on short and medium term in different clinical situations, predictive factors of rebleeding after Hemospray™ application, and feasibility of the application of hemostatic powder in routine clinical practice studying in a large sample of patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • Angers University Hospital
      • Besançon, France, 25030
        • Besançon University Hospital
      • Bordeaux, France, 33076
        • Bordeuax University Hospital
      • Lille, France, 59037
        • Lille University Hospital
      • Limoges, France, 87042
        • Limoges university hospital
      • Marseille, France, 13005
        • La Conception University Hospital
      • Marseille, France, 13005
        • La Timone University Hospital
      • Nantes, France, 44093
        • Nantes University Hospital
      • Nîmes, France, 30029
        • Nîmes University Hospital
      • Paris, France, 75000
        • Cochin University Hospital
      • Paris, France, 75000
        • Georges Pompidou University Hospital (AP-HP)
      • Paris, France, 75000
        • Henri Mondor University Hospital (AP-HP)
      • Paris, France, 75000
        • Lariboisière University Hospital (AP-HP)
      • Rouen, France, 76031
        • ROUEN university hospital
      • Saint-Brieuc, France, 22000
        • Saint-Brieuc University Hospital
      • Toulouse, France, 31000
        • Clinique des Cèdres
      • Tours, France, 37044
        • Tours university Hospital
      • Vichy, France, 03200
        • Vichy Hospital
  • Monaco
      • Monaco, Monaco, 98012
        • Monaco University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adult patients who received hemostatic powder for upper GI bleeding will be included in the study. Pregnant and adult under guardianship will be excluded.

Description

Inclusion Criteria:

  • Male or female aged 18 and over who need the use of Hemospray® under their care in an emergency.
  • Upper gastrointestinal hemorrhage.
  • Patients who received the information note of the study and agreeing to participate (non-oral opposition gathered in the patient's medical record)

Non Inclusion Criteria:

  • Patient under guardianship, curatorship.
  • Pregnant woman.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of immediate cessation of bleeding observed in first-line per procedure or after failure of normal hemostasis techniques.
Time Frame: 30 days
Percentage of immediate cessation of bleeding observed in first-line per procedure or after failure of normal hemostasis techniques.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rebleeding rate at days 8 and 30, defined as the percentage of patients with >2g/dL hemoglobin AND/OR exteriorization of hematemesis AND/OR exteriorization of melena
Time Frame: 30 days
Rebleeding rate at days 8 and 30, defined as the percentage of patients with >2g/dL hemoglobin AND/OR exteriorization of hematemesis AND/OR exteriorization of melena
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

October 29, 2015

First Submitted That Met QC Criteria

November 2, 2015

First Posted (Estimate)

November 4, 2015

Study Record Updates

Last Update Posted (Actual)

September 10, 2021

Last Update Submitted That Met QC Criteria

September 8, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC14_0077

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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