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

NCT02005705 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2016-07-14

No results posted yet for this study

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.

Conditions

  • Upper Gastrointestinal Bleeding

Interventions

OTHER

Outpatient 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

OTHER

Inpatient 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 & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Loren Laine, MD · Yale University, Section of Digestive Disease

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02005705 on ClinicalTrials.gov