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Risk Scoring Systems in Upper GI-haemorrhage

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stig Borbjerg Laursen, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01589250
First received: April 27, 2012
Last updated: April 30, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition
Upper Gastrointestinal Hemorrhage

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Risk Scoring Systems in Upper GI-haemorrhage

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Need for hospital-based intervention [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    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:
  • Identification of low-risk patients [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 831
Study Start Date: August 2009
Study Completion Date: April 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

Criteria

Inclusion Criteria:

One of the following:

  • Haematemesis
  • Melaena
  • Coffee-ground vomit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589250

Locations
Denmark
Odense University Hospital
Odense, Denmark
Sponsors and Collaborators
Odense University Hospital
  More Information

No publications provided

Responsible Party: Stig Borbjerg Laursen, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01589250     History of Changes
Other Study ID Numbers: SBL-03
Study First Received: April 27, 2012
Last Updated: April 30, 2012
Health Authority: Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Hemorrhage
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013