Clinical Trial: Efficacy of a Novel Hemostatic Powder in GI Bleeding

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: A Novel Hemostatic Powder for the Endoscopic Treatment of Gastrointestinal Bleeding: Evaluation of Efficacy, Feasibility and Rebleeding Predictive Factors Results From a M

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 Summary:
Sponsor: Nantes University Hospital

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

Original Primary Outcome: Same as current

Current Secondary Outcome: 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 ]

Original Secondary Outcome: Same as current

Information By: Nantes University Hospital

Dates:
Date Received: October 29, 2015
Date Started: October 2014
Date Completion:
Last Updated: November 2, 2015
Last Verified: October 2015