Efficacy of a Novel Hemostatic Powder in GI Bleeding

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.

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Key information

Conditions

Gastrointestinal Bleeding Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Angers University Hospital, Angers, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

Percentage of immediate cessation of bleeding observed in first-line per procedure or after failure of normal hemostasis techniques.

Time frame: 30 days

Percentage of immediate cessation of bleeding observed in first-line per procedure or after failure of normal hemostasis techniques.

Secondary outcomes

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

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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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

Acronym: GRAPHE

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Nov 4, 2015
Registry last updated: Sep 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed