Randomized Trial of Outpatient vs. Inpatient Management of Low-risk Patients With Upper Gastrointestinal Bleeding.

Yale University

Status: Terminated

Conditions: Upper Gastrointestinal Bleeding

Treatments: Other: Outpatient Management of Low-risk Patients; Other: Inpatient Management of Low-risk Patients

Study type: Interventional

Funder types: Other

Identifiers

NCT02005705

HIC 1307012373

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

17 participants in 2 patient groups

Outpatient

Active Comparator group

Treatment:

Other: Outpatient Management of Low-risk Patients

Inpatient

Active Comparator group

Treatment:

Other: Inpatient Management of Low-risk Patients