Glasgow-Blatschford Score Validation in Digestive Hemorrhage

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Gastrointestinal Hemorrhage	Procedure: Endoscopy	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	64 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	Glasgow-Blatschford Score Validation for Stratification of Patients With Digestive Hemorrhage
Study Start Date :	October 2009
Estimated Primary Completion Date :	June 2010
Estimated Study Completion Date :	March 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Endoscopy; If the Glasgow-Blatchford score is zero, the endoscopy is delayed as an outpatient	Procedure: Endoscopy; Realization of an upper GI endoscopy

Outcome Measures

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Primary Outcome Measures :

1. Comparison of length of stay between patients with score equal to zero and above zero [ Time Frame: june 2010 ]

Secondary Outcome Measures :

1. Determination of the proportion of low risk upper gastrointestinal bleeding [ Time Frame: june 2010 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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. doi: 10.1016/S0140-6736(08)61769-9. 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
First Posted:	December 10, 2009
Last Update Posted:	December 10, 2009
Last Verified:	October 2009

Additional relevant MeSH terms:

Hemorrhage; Gastrointestinal Hemorrhage; Pathologic Processes; Gastrointestinal Diseases; Digestive System Diseases