Efficacy of a Novel Hemostatic Powder in GI Bleeding | NCT02595853 | Trialant

Efficacy of a Novel Hemostatic Powder in GI Bleeding | NCT02595853 | Trialant

Arms/Interventions Module

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non interventional study	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

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	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

Contacts/Locations Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27760437	Derived	Haddara S, Jacques J, Lecleire S, Branche J, Leblanc S, Le Baleur Y, Privat J, Heyries L, Bichard P, Granval P, Chaput U, Koch S, Levy J, Godart B, Charachon A, Bourgaux JF, Metivier-Cesbron E, Chabrun E, Quentin V, Perrot B, Vanbiervliet G, Coron E. A novel hemostatic powder for upper gastrointestinal bleeding: a multicenter study (the "GRAPHE" registry). Endoscopy. 2016 Dec;48(12):1084-1095. doi: 10.1055/s-0042-116148. Epub 2016 Oct 19.

Condition Browse Module