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

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 Overview

• Status: Terminated
• Conditions: Upper Gastrointestinal Bleeding
• Intervention / Treatment: Other: Outpatient Management of Low-risk Patients; Other: Inpatient Management of Low-risk Patients

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Outpatient	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
Active Comparator: Inpatient	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Loren Laine, MD, Yale University, Section of Digestive Disease

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: December 3, 2013
• First Submitted That Met QC Criteria: December 6, 2013
• First Posted (Estimate): December 9, 2013

Study Record Updates

• Last Update Posted (Estimate): July 14, 2016
• Last Update Submitted That Met QC Criteria: July 12, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: HIC 1307012373