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

Upper Gastrointestinal Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02005705
• Other study ID #: HIC 1307012373
• Status: Terminated
• Phase: N/A
• First received: December 3, 2013
• Last updated: July 12, 2016
• Start date: December 2013
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Upper Gastrointestinal Bleeding

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes