Risk Scoring Systems in Upper GI-haemorrhage

Completed

• Conditions: Upper Gastrointestinal Hemorrhage

• Registration Number: NCT01589250
• Lead Sponsor: Odense University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2011-08
• Status Verified: 2012-04
• Study Completion: 2012-04
• Study First Submitted: 2012-04-27
• Study First Submitted QC: 2012-04-30
• Last Update Submitted: 2012-04-30
• Study First Posted: 2012-05-01
• Last Update Posted: 2012-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 831

Inclusion Criteria

One of the following:

• Haematemesis
• Melaena
• Coffee-ground vomit

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Need for hospital-based intervention	1 month	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.

Secondary Outcome Measures

Name	Time	Method
Identification of low-risk patients	1 month	Low-risk patients were defined as patients who did not need hospital-based intervention, and survived more than 30 days from day of admission. Low-risk patients were considered as suitable for early discharge and potential outpatient management.
Rebleeding	1 month	Rebleeding was defined as presence of hematemesis, blood per nasogastric tube, or melaena associated with a decline in B-hemoglobin of at least 1mmol/l (not explained by hemodilution) or decline in systolic arterial pressure of at least 20mmHg after the initial bleeding had stopped.
30 day mortality	30 days

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark