Glasgow-Blatschford Score Validation in Digestive Hemorrhage

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2009 by University Hospital, Geneva.
Recruitment status was Recruiting

Sponsor:

Information provided by:

University Hospital, Geneva

ClinicalTrials.gov Identifier:

NCT01029626

First received: December 9, 2009

Last updated: NA

Last verified: October 2009

History: No changes posted

Purpose

The purpose of this study is to validate the Glasgow-Blatchford score for the stratification of patients with upper gastro-intestinal hemorrhage. This score is easy to calculate. It is mainly based on the hemoglobin, blood pressure and blood urea. if the score is zero, the bleeding is very low risk and the gastrointestinal endoscopy may be delayed and performed as an outpatient.

Condition	Intervention
Gastrointestinal Hemorrhage	Procedure: Endoscopy

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Glasgow-Blatschford Score Validation for Stratification of Patients With Digestive Hemorrhage

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy Gastrointestinal Bleeding

U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:

Comparison of length of stay between patients with score equal to zero and above zero [ Time Frame: june 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Determination of the proportion of low risk upper gastrointestinal bleeding [ Time Frame: june 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment:	64
Study Start Date:	October 2009
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Endoscopy If the Glasgow-Blatchford score is zero, the endoscopy is delayed as an outpatient	Procedure: Endoscopy Realization of an upper GI endoscopy

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

To be admitted in the university hospital for a gastrointestinal hemorrhage (vomiting of red or black blood or melena)

Exclusion Criteria:

Age under 18
Pregnancy
Hemorrhage during hospitalisation
red rectal bleeding
No consent signed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029626

Contacts

Contact: Marc Girardin, MD

+41223729340

marc.girardin@hcuge.ch

Locations

Switzerland
Geneva University Hospital	Recruiting
Geneva, Switzerland, 1211
Contact: Marc Girardin, MD +41223729340 marc.girardin@hcuge.ch
Principal Investigator: Marc Girardin, MD
Sub-Investigator: Jean-Marc Dumonceau, MD

Sponsors and Collaborators

University Hospital, Geneva

Investigators

Principal Investigator:

Marc Girardin, MD

Geneva University Hospital

More Information

Publications:

Blatchford O, Murray WR, Blatchford M. A risk score to predict need for treatment for upper-gastrointestinal haemorrhage. Lancet. 2000 Oct 14;356(9238):1318-21.

Stanley AJ, Ashley D, Dalton HR, Mowat C, Gaya DR, Thompson E, Warshow U, Groome M, Cahill A, Benson G, Blatchford O, Murray W. Outpatient management of patients with low-risk upper-gastrointestinal haemorrhage: multicentre validation and prospective evaluation. Lancet. 2009 Jan 3;373(9657):42-7. Epub 2008 Dec 16.

Responsible Party:	Marc Girardin Dr, Geneva University Hospital
ClinicalTrials.gov Identifier:	NCT01029626 History of Changes
Other Study ID Numbers:	09-091
Study First Received:	December 9, 2009
Last Updated:	December 9, 2009
Health Authority:	Switzerland: Ethikkommission

Additional relevant MeSH terms:

Gastrointestinal Hemorrhage
Hemorrhage
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013

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