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

Not Applicable

Terminated

• Conditions: Upper Gastrointestinal Bleeding
• Interventions: Other: Outpatient Management of Low-risk Patients; Other: Inpatient Management of Low-risk Patients

• Registration Number: NCT02005705
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-06
• Study First Posted: 2013-12-09
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-12
• Last Update Posted: 2016-07-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Outpatient	Outpatient Management of Low-risk Patients	-
Inpatient	Inpatient Management of Low-risk Patients	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States