Efficacy of a Novel Hemostatic Powder in GI Bleeding

Gastrointestinal Bleeding Clinical Trial

— GRAPHE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02595853
• Other study ID #: RC14_0077
• Status: Completed
• Start date: October 2014
• Est. completion date: January 2015

Study information

• Verified date: September 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Bleeding
• Gastrointestinal Hemorrhage
• Hemorrhage

Intervention

Other:
• Non interventional study
All upper gastro-intestinal bleeding need endoscopic hemostasis. Endoscopic hemostasis conventional methods are injection of saline with epinephrine, placement of hemoclips and thermic or plasma coagulation. Hemospray™ will be sprayed onto bleeding lesions seen in endoscopy after failure of conventional methods or in salvage therapy at the discretion of endoscopists. Retrospective analysis of prospectively cellected data.

Locations

Country	Name	City	State
France	Angers University Hospital	Angers
France	Besançon University Hospital	Besançon
France	Bordeuax University Hospital	Bordeaux
France	Lille University Hospital	Lille
France	Limoges University Hospital	Limoges
France	La Conception University Hospital	Marseille
France	La Timone University Hospital	Marseille
France	Nantes University Hospital	Nantes
France	Nîmes University Hospital	Nîmes
France	Cochin University Hospital	Paris
France	Georges Pompidou University Hospital (AP-HP)	Paris
France	Henri Mondor University Hospital (AP-HP)	Paris
France	Lariboisière University Hospital (AP-HP)	Paris
France	Rouen University Hospital	Rouen
France	Saint-Brieuc University Hospital	Saint-Brieuc
France	Clinique des Cèdres	Toulouse
France	Tours University Hospital	Tours
France	Vichy Hospital	Vichy
Monaco	Monaco University Hospital	Monaco

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Countries where clinical trial is conducted

France,  Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of immediate cessation of bleeding observed in first-line per procedure or after failure of normal hemostasis techniques.	Percentage of immediate cessation of bleeding observed in first-line per procedure or after failure of normal hemostasis techniques.	30 days
Secondary	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	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

External Links

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