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Risk Scoring Systems in Upper GI-haemorrhage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01589250
Recruitment Status : Completed
First Posted : May 1, 2012
Last Update Posted : May 1, 2012
Information provided by (Responsible Party):
Stig Borbjerg Laursen, 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.

Condition or disease
Upper Gastrointestinal Hemorrhage

Study Type : Observational
Actual Enrollment : 831 participants
Time Perspective: Prospective
Official Title: Risk Scoring Systems in Upper GI-haemorrhage
Study Start Date : August 2009
Primary Completion Date : August 2011
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Need for hospital-based intervention [ Time Frame: 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 :
  1. Identification of low-risk patients [ Time Frame: 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.

  2. Rebleeding [ Time Frame: 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.

  3. 30 day mortality [ Time Frame: 30 days ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Inclusion Criteria:

One of the following:

  • Haematemesis
  • Melaena
  • Coffee-ground vomit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01589250

Odense University Hospital
Odense, Denmark
Sponsors and Collaborators
Odense University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Stig Borbjerg Laursen, MD, Odense University Hospital Identifier: NCT01589250     History of Changes
Other Study ID Numbers: SBL-03
First Posted: May 1, 2012    Key Record Dates
Last Update Posted: May 1, 2012
Last Verified: April 2012

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