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

N/ATerminatedNCT02005705

Yale University17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Upper Gastrointestinal Bleeding

Interventions

Outpatient Management of Low-risk PatientsOTHER

* 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

Inpatient Management of Low-risk PatientsOTHER

* 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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Yale New Haven Hospital

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

The number of patients requiring intervention for UGIB (endoscopic therapy, blood transfusion, surgery, interventional radiology)

Time frame: Within 7 days of the index presentation to the emergency room

Data from ClinicalTrials.gov

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