Risk Scoring Systems in Upper GI-haemorrhage

Upper Gastrointestinal Hemorrhage Clinical Trial

Official title:

Risk Scoring Systems in Upper GI-haemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01589250
• Other study ID #: SBL-03
• Status: Completed
• Phase: N/A
• First received: April 27, 2012
• Last updated: April 30, 2012
• Start date: August 2009
• Est. completion date: April 2012

Study information

• Verified date: April 2012
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 831
• Est. completion date: April 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

One of the following:

• Haematemesis

• Melaena

• Coffee-ground vomit

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Upper Gastrointestinal Hemorrhage

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Identification of low-risk patients	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.	1 month	Yes
Secondary	Rebleeding	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.	1 month	Yes
Secondary	30 day mortality		30 days	Yes