Efficacy of a Novel Hemostatic Powder in GI Bleeding

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Gastrointestinal Bleeding

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Non 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.

Intervention Type OTHER

Eligibility Criteria

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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)

* Patient under guardianship, curatorship.
* Pregnant woman.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No