Efficacy of a Novel Hemostatic Powder in GI Bleeding

Nantes University Hospital200 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

200

Conditions

Gastrointestinal Bleeding

Interventions

Non interventional studyOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (19)

Angers University Hospital

Angers, France

Besançon University Hospital

Besançon, France

Outcomes

Primary Outcomes

Percentage of immediate cessation of bleeding observed in first-line per procedure or after failure of normal hemostasis techniques.

Time frame: 30 days

Secondary Outcomes

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

Time frame: 30 days

Data from ClinicalTrials.gov

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