Efficacy of a Novel Hemostatic Powder in GI Bleeding

• Register: ClinicalTrials.gov
• Last refreshed on: 20 September 2021
• Main ID: NCT02595853
• Date of registration: 29/10/2015
• Prospective Registration: No
• Primary sponsor: Nantes University Hospital
• Public title: Efficacy of a Novel Hemostatic Powder in GI Bleeding GRAPHE
• Scientific 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
• Date of first enrolment: October 2014
• Target sample size: 200
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02595853
• Study type: Observational

Countries of recruitment

France, Monaco

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Gastrointestinal Bleeding

Intervention(s)

Other: Non interventional study

Primary Outcome(s)

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

Secondary Outcome(s)

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]

Secondary ID(s)

RC14_0077

Source(s) of Monetary Support

Please refer to primary and secondary sponsors