Randomized Trial of Outpatient vs. Inpatient Management of Low-risk Patients With Upper Gastrointestinal Bleeding.
Stopped early · Not applicable
Conditions studied: Upper Gastrointestinal Bleeding
In brief
Patients presenting to the emergency room with upper gastrointestinal bleeding and a Glasgow Blatchford score of zero will be randomly assigned to further care in the inpatient vs. outpatient setting. The hypothesis of this study is that patients who are managed as outpatients will require interventions at a rate not higher than those managed as inpatients and will have lower direct healthcare costs.
Key facts
- Study ID
- NCT02005705
- Run by
- Yale University
- People needed
- 17
- Starts
- 2013-12-01
- Expected to finish
- 2016-06-01
- Last updated by the study team
- 2016-07-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Blood Urea Nitrogen < 18.2 mg/dl
- Hemoglobin ≥ 13.0 g/dl for men and ≥ 12.0 g/dl for women
- Systolic blood pressure ≥ 110 mm Hg
- Heart rate < 100 beats/min
You may not qualify if…
- Inability to obtain informed consent
- Pregnancy
- History of liver disease
- History of heart failure
- Syncope that is temporally related to ongoing bleeding
- Melena
- Contraindication to proton pump inhibitor use
- Other conditions that necessitate inpatient evaluation.
- Inpatients with new onset of GI bleeding
Where it is running
- Yale New Haven Hospital — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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