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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Upper Gastrointestinal Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Outpatient

Group Type ACTIVE_COMPARATOR

Outpatient Management of Low-risk Patients

Intervention Type OTHER

* 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

Group Type ACTIVE_COMPARATOR

Inpatient Management of Low-risk Patients

Intervention Type OTHER

* 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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No