NCT01589250

Brief Summary

Use of risk scoring systems in the assessment of patients presenting with upper gastrointestinal haemorrhage is increasing. Comparative studies have intended to identify the system of choice, but the majority of these are characterized by retrospective designs, small sample sizes, low rate of severe bleeding, or low mortality. The main aim of this study was to identify the optimal scoring system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
831

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2009

Typical duration for all trials

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

August 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 1, 2012

Completed
Last Updated

May 1, 2012

Status Verified

April 1, 2012

Enrollment Period

2 years

First QC Date

April 27, 2012

Last Update Submit

April 30, 2012

Conditions

Upper Gastrointestinal Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Need for hospital-based intervention

    Need of hospital-based intervention was defined as treatment with blood transfusion, endoscopic therapy, transcatheter arterial embolization (TAE), surgery, or identification of cancer at upper endoscopy.

    1 month

Secondary Outcomes (3)

  • Identification of low-risk patients

    1 month

  • Rebleeding

    1 month

  • 30 day mortality

    30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Data were collected from consecutive patients admitted with UGIH at Odense University Hospital between August 2009 and August 2011. UGIH was defined as history of haematemesis, coffee-ground vomit, or melaena.

You may qualify if:

  • One of the following:
  • Haematemesis
  • Melaena
  • Coffee-ground vomit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, Denmark

Location

Related Publications (1)

  • Laursen SB, Hansen JM, Schaffalitzky de Muckadell OB. The Glasgow Blatchford score is the most accurate assessment of patients with upper gastrointestinal hemorrhage. Clin Gastroenterol Hepatol. 2012 Oct;10(10):1130-1135.e1. doi: 10.1016/j.cgh.2012.06.022. Epub 2012 Jul 16.

    PMID: 22801061DERIVED

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 27, 2012

First Posted

May 1, 2012

Study Start

August 1, 2009

Primary Completion

August 1, 2011

Study Completion

April 1, 2012

Last Updated

May 1, 2012

Record last verified: 2012-04

Locations

DK(1)