Upper Gastrointestinal Bleeding
Conditions
Brief summary
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.
Interventions
OTHEROutpatient Management of Low-risk Patients
* Labs will be obtained within 2-3 days of discharge from ED * Clinic visit will be scheduled within 3 days of discharge from ED * EGD will be scheduled within 7 days of discharge from ED * Phone follow-up at day 7 and 30
OTHERInpatient Management of Low-risk Patients
* Labs will be obtained on day of discharge or day 2-3 * EGD will be performed in the hospital * Phone follow-up at day 7 and 30
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Blood Urea Nitrogen \< 18.2 mg/dl 2. Hemoglobin ≥ 13.0 g/dl for men and ≥ 12.0 g/dl for women 3. Systolic blood pressure ≥ 110 mm Hg 4. Heart rate \< 100 beats/min
Exclusion criteria
1. Inability to obtain informed consent 2. Pregnancy 3. History of liver disease 4. History of heart failure 5. Syncope that is temporally related to ongoing bleeding 6. Melena 7. Contraindication to proton pump inhibitor use 8. Other conditions that necessitate inpatient evaluation. 9. Inpatients with new onset of GI bleeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of patients requiring intervention for UGIB (endoscopic therapy, blood transfusion, surgery, interventional radiology) | Within 7 days of the index presentation to the emergency room |
Countries
United States
Outcome results
None listed