search
Back to results

Glasgow-Blatschford Score Validation in Digestive Hemorrhage

Primary Purpose

Gastrointestinal Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Endoscopy
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastrointestinal Hemorrhage

Eligibility Criteria

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

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

Sites / Locations

  • Geneva University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Endoscopy

Arm Description

If the Glasgow-Blatchford score is zero, the endoscopy is delayed as an outpatient

Outcomes

Primary Outcome Measures

Comparison of length of stay between patients with score equal to zero and above zero

Secondary Outcome Measures

Determination of the proportion of low risk upper gastrointestinal bleeding

Full Information

First Posted
December 9, 2009
Last Updated
May 30, 2018
Sponsor
University Hospital, Geneva
search

1. Study Identification

Unique Protocol Identification Number
NCT01029626
Brief Title
Glasgow-Blatschford Score Validation in Digestive Hemorrhage
Official Title
Glasgow-Blatschford Score Validation for Stratification of Patients With Digestive Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Hemorrhage

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endoscopy
Arm Type
Other
Arm Description
If the Glasgow-Blatchford score is zero, the endoscopy is delayed as an outpatient
Intervention Type
Procedure
Intervention Name(s)
Endoscopy
Intervention Description
Realization of an upper GI endoscopy
Primary Outcome Measure Information:
Title
Comparison of length of stay between patients with score equal to zero and above zero
Time Frame
june 2010
Secondary Outcome Measure Information:
Title
Determination of the proportion of low risk upper gastrointestinal bleeding
Time Frame
june 2010

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Girardin, MD
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geneva University Hospital
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
11073021
Citation
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. doi: 10.1016/S0140-6736(00)02816-6.
Results Reference
background
PubMed Identifier
19091393
Citation
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.
Results Reference
background

Learn more about this trial

Glasgow-Blatschford Score Validation in Digestive Hemorrhage

We'll reach out to this number within 24 hrs