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HDUPE 2004: Gastro-Oesophageal Haemorrhage in Emergency : Gastric Préparation to Endoscopy

Primary Purpose

Upper Gastrointestinal Bleeding

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
erythomycin
gastric lavage alone
erythromycine and gastric lavage
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Upper Gastrointestinal Bleeding focused on measuring Bleeding, Endoscopy, Gastric tube, Erythromycin, Randomized

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Hematemesis or melaena No QT enlargement Exclusion Criteria: Refusing endoscopy Glasgow < 15

Sites / Locations

  • Hôpital Jean VERDIER

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Active Comparator

Arm Label

drug

2

3

Arm Description

erythromycine

gastric lavage alone

erythromycine and gastric lavage

Outcomes

Primary Outcome Measures

Endoscopic yield

Secondary Outcome Measures

Rebleeding until D 30, transfusion, gastric tube or erythromycin complications

Full Information

First Posted
November 28, 2005
Last Updated
September 30, 2008
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00259220
Brief Title
HDUPE 2004: Gastro-Oesophageal Haemorrhage in Emergency : Gastric Préparation to Endoscopy
Official Title
In Urgency Hight Digestive Haemorrhage : Gastric Preparation for Endoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Gastric lavage is usually used for gastric preparation before endoscopy in patients with upper gastrointestinal bleeding. However, the benefit-risk balance of putting a nasogastric tube in these patients is not clearly defined. This randomized trial is aimed to determine if the use of erythromycin IV before endoscopy could avoid to put a gastric tube for the management of upper gastrointestinal bleeding.
Detailed Description
Acute upper gastrointestinal haemorrhage is one of the main digestive emergencies involving hospital admission. Endoscopic examination plays a key role to determine the cause of the bleeding and to carry out a therapeutic procedure. Endoscopic performance depends on the quality of the examination that may be hampered by residual blood in the gastric cavity. Gastric lavage is usually performed to clear the stomach. However, several teams consider that it is possible to avoid putting a nasogastric tube because it is ineffective in half of the patients, disagreeable in most of them, can induce side effects and need a long time work for nurses. It could be replaced by the use of Erythromycin. There are no official recommendations in that field. Recent studies have shown that Erythromycin, a macrolide antibiotic with gastro kinetic properties can accelerate gastric emptying by inducing gastric contraction. This motilin receptor agonist could improve the gastric cleaning and the quality of endoscopic examination and decrease its duration. This randomized trial is aimed to determine if the use of erythromycin IV before endoscopy could avoid putting a gastric tube for the management of upper gastrointestinal bleeding. It is a prospective, controlled, randomized, multicentric study with a blind assessment of the main criteria. All patients aged more than 18 years with an acute upper gastrointestinal bleeding, defined by melena or hematemesis, managed by emergency department are enrolled. 270 patients are expected. Informed consent including for endoscopic examination and no contraindication for using Erythromycin (QT enlargement) is needed. Patients are randomized in three groups: Erythromycin alone, nasogastric tube with gastric lavage alone or both Erythromycin and nasogastric tube. Patients are followed-up until first month after bleeding. The main criteria are the visualization of the gastric tract and the other criteria are rebleeding until D 30, transfusion, gastric tube or erythromycin complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Gastrointestinal Bleeding
Keywords
Bleeding, Endoscopy, Gastric tube, Erythromycin, Randomized

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
drug
Arm Type
Experimental
Arm Description
erythromycine
Arm Title
2
Arm Type
Other
Arm Description
gastric lavage alone
Arm Title
3
Arm Type
Active Comparator
Arm Description
erythromycine and gastric lavage
Intervention Type
Drug
Intervention Name(s)
erythomycin
Intervention Description
erythomycin
Intervention Type
Procedure
Intervention Name(s)
gastric lavage alone
Intervention Description
gastric lavage alone
Intervention Type
Procedure
Intervention Name(s)
erythromycine and gastric lavage
Intervention Description
erythromycine and gastric lavage
Primary Outcome Measure Information:
Title
Endoscopic yield
Time Frame
at the beggining of the study
Secondary Outcome Measure Information:
Title
Rebleeding until D 30, transfusion, gastric tube or erythromycin complications
Time Frame
until 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hematemesis or melaena No QT enlargement Exclusion Criteria: Refusing endoscopy Glasgow < 15
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique PATERON, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Jean VERDIER
City
Bondy
ZIP/Postal Code
93140
Country
France

12. IPD Sharing Statement

Learn more about this trial

HDUPE 2004: Gastro-Oesophageal Haemorrhage in Emergency : Gastric Préparation to Endoscopy

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