Clinical trial NCT02595853: Efficacy of a Novel Hemostatic Powder in GI Bleeding
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Bleeding
Keywords: Upper GastroIntestinal bleeding, endoscopy, Hemospray
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2015-11-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients who received hemostatic powder for upper GI bleeding will be included in the study. Pregnant and adult under guardianship will be excluded.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of immediate cessation of bleeding observed in first-line per procedure or after failure of normal hemostasis techniques.
timeFrame: 30 days
Secondary outcomes:
measure: 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
timeFrame: 30 days
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Besançon
country: France
facility: Besançon University Hospital
city: Bordeaux
country: France
facility: Bordeuax University Hospital
city: Lille
country: France
facility: Lille University Hospital
city: Limoges
country: France
facility: Limoges University Hospital
city: Marseille
country: France
facility: La Conception University Hospital
city: Marseille
country: France
facility: La Timone University Hospital
city: Nantes
country: France
facility: Nantes University Hospital
city: Nîmes
country: France
facility: Nîmes University Hospital
city: Paris
country: France
facility: Cochin University Hospital
city: Paris
country: France
facility: Georges Pompidou University Hospital (AP-HP)
city: Paris
country: France
facility: Henri Mondor University Hospital (AP-HP)
city: Paris
country: France
facility: Lariboisière University Hospital (AP-HP)
city: Rouen
country: France
facility: Rouen University Hospital
city: Saint-Brieuc
country: France
facility: Saint-Brieuc University Hospital
city: Toulouse
country: France
facility: Clinique des Cèdres
city: Tours
country: France
facility: Tours University Hospital
city: Vichy
country: France
facility: Vichy Hospital
city: Monaco
country: Monaco
facility: Monaco University Hospital
Study officials:
References:
citation: 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.