NCT01029626

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 10, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 1, 2018

Status Verified

May 1, 2018

Enrollment Period

8 months

First QC Date

December 9, 2009

Last Update Submit

May 30, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

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

    june 2010

Secondary Outcomes (1)

  • Determination of the proportion of low risk upper gastrointestinal bleeding

    june 2010

Study Arms (1)

Endoscopy

OTHER

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

Procedure: Endoscopy

Interventions

EndoscopyPROCEDURE

Realization of an upper GI endoscopy

Endoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva University Hospital

Geneva, 1211, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 11073021BACKGROUND
  • 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.

    PMID: 19091393BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Marc Girardin, MD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 9, 2009

First Posted

December 10, 2009

Study Start

October 1, 2009

Primary Completion

June 1, 2010

Study Completion

December 1, 2014

Last Updated

June 1, 2018

Record last verified: 2018-05

Locations