Efficacy of a Novel Hemostatic Powder in GI Bleeding

Completed

• Conditions: Gastrointestinal Bleeding

• Registration Number: NCT02595853
• Lead Sponsor: Nantes University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Study First Submitted: 2015-10-29
• Study First Submitted QC: 2015-11-02
• Study First Posted: 2015-11-04
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-08
• Last Update Posted: 2021-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of immediate cessation of bleeding observed in first-line per procedure or after failure of normal hemostasis techniques.	30 days	Percentage of immediate cessation of bleeding observed in first-line per procedure or after failure of normal hemostasis techniques.

Secondary Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (19)

Limoges University Hospital; 🇫🇷 Limoges, France

Bordeuax University Hospital; 🇫🇷 Bordeaux, France

Lille University Hospital; 🇫🇷 Lille, France

La Conception University Hospital; 🇫🇷 Marseille, France

Georges Pompidou University Hospital (AP-HP); 🇫🇷 Paris, France

Angers University Hospital; 🇫🇷 Angers, France

La Timone University Hospital; 🇫🇷 Marseille, France

Nantes University Hospital; 🇫🇷 Nantes, France

Saint-Brieuc University Hospital; 🇫🇷 Saint-Brieuc, France

Vichy Hospital; 🇫🇷 Vichy, France

Besançon University Hospital; 🇫🇷 Besançon, France

Nîmes University Hospital; 🇫🇷 Nîmes, France

Henri Mondor University Hospital (AP-HP); 🇫🇷 Paris, France

Lariboisière University Hospital (AP-HP); 🇫🇷 Paris, France

Rouen University Hospital; 🇫🇷 Rouen, France

Cochin University Hospital; 🇫🇷 Paris, France

Clinique des Cèdres; 🇫🇷 Toulouse, France

Tours University Hospital; 🇫🇷 Tours, France

Monaco University Hospital; 🇲🇨 Monaco, Monaco