Efficacy of a Novel Hemostatic Powder in GI Bleeding

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02595853

Acronym

GRAPHE

Enrollment

200

Registered

2015-11-04

Start date

2014-10-31

Completion date

2015-01-31

Last updated

2021-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Bleeding

Keywords

Upper GastroIntestinal bleeding, endoscopy, Hemospray

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.

Interventions

OTHERNon interventional study

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of immediate cessation of bleeding observed in first-line per procedure or after failure of normal hemostasis techniques.	30 days	Percentage of immediate cessation of bleeding observed in first-line per procedure or after failure of normal hemostasis techniques.

Secondary

Measure	Time frame	Description
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	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

Countries

France, Monaco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026