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

Primary Purpose

Upper Gastrointestinal Bleeding

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Outpatient Management of Low-risk Patients
Inpatient Management of Low-risk Patients
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Upper Gastrointestinal Bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Yale New Haven Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Outpatient

Inpatient

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 3, 2013
Last Updated
July 12, 2016
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT02005705
Brief Title
Randomized Trial of Outpatient vs. Inpatient Management of Low-risk Patients With Upper Gastrointestinal Bleeding.
Official Title
Randomized Trial of Outpatient vs. Inpatient Management of Low-risk Patients With Upper Gastrointestinal Bleeding.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
Inadequate recruitment
Study Start Date
December 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Gastrointestinal Bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Outpatient
Arm Type
Active Comparator
Arm Title
Inpatient
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Outpatient Management of Low-risk Patients
Intervention Description
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
Intervention Name(s)
Inpatient Management of Low-risk Patients
Intervention Description
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
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Blood Urea Nitrogen < 18.2 mg/dl Hemoglobin ≥ 13.0 g/dl for men and ≥ 12.0 g/dl for women Systolic blood pressure ≥ 110 mm Hg Heart rate < 100 beats/min Exclusion Criteria: Inability to obtain informed consent Pregnancy History of liver disease History of heart failure Syncope that is temporally related to ongoing bleeding Melena Contraindication to proton pump inhibitor use Other conditions that necessitate inpatient evaluation. Inpatients with new onset of GI bleeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loren Laine, MD
Organizational Affiliation
Yale University, Section of Digestive Disease
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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