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Glasgow-Blatschford Score Validation in Digestive Hemorrhage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01029626
Recruitment Status : Completed
First Posted : December 10, 2009
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Marc Girardin, University Hospital, Geneva

Tracking Information
First Submitted Date  ICMJE December 9, 2009
First Posted Date  ICMJE December 10, 2009
Last Update Posted Date June 1, 2018
Study Start Date  ICMJE October 2009
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2009)
Comparison of length of stay between patients with score equal to zero and above zero [ Time Frame: june 2010 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01029626 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2009)
Determination of the proportion of low risk upper gastrointestinal bleeding [ Time Frame: june 2010 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Glasgow-Blatschford Score Validation in Digestive Hemorrhage
Official Title  ICMJE Glasgow-Blatschford Score Validation for Stratification of Patients With Digestive Hemorrhage
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Gastrointestinal Hemorrhage
Intervention  ICMJE Procedure: Endoscopy
Realization of an upper GI endoscopy
Study Arms  ICMJE Endoscopy
If the Glasgow-Blatchford score is zero, the endoscopy is delayed as an outpatient
Intervention: Procedure: Endoscopy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2018)
208
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2009)
64
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01029626
Other Study ID Numbers  ICMJE 09-091
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marc Girardin, University Hospital, Geneva
Study Sponsor  ICMJE University Hospital, Geneva
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marc Girardin, MD University Hospital, Geneva
PRS Account University Hospital, Geneva
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP