Gastrointestinal Bleeding Clinical Trial
— GRAPHEOfficial 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
NCT number | NCT02595853 |
Other study ID # | RC14_0077 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2014 |
Est. completion date | January 2015 |
Verified date | September 2021 |
Source | Nantes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | January 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Angers University Hospital | Angers | |
France | Besançon University Hospital | Besançon | |
France | Bordeuax University Hospital | Bordeaux | |
France | Lille University Hospital | Lille | |
France | Limoges University Hospital | Limoges | |
France | La Conception University Hospital | Marseille | |
France | La Timone University Hospital | Marseille | |
France | Nantes University Hospital | Nantes | |
France | Nîmes University Hospital | Nîmes | |
France | Cochin University Hospital | Paris | |
France | Georges Pompidou University Hospital (AP-HP) | Paris | |
France | Henri Mondor University Hospital (AP-HP) | Paris | |
France | Lariboisière University Hospital (AP-HP) | Paris | |
France | Rouen University Hospital | Rouen | |
France | Saint-Brieuc University Hospital | Saint-Brieuc | |
France | Clinique des Cèdres | Toulouse | |
France | Tours University Hospital | Tours | |
France | Vichy Hospital | Vichy | |
Monaco | Monaco University Hospital | Monaco |
Lead Sponsor | Collaborator |
---|---|
Nantes University Hospital |
France, Monaco,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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