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

NCT02005705 | Terminated

• 1 other identifier: HIC 1307012373
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Gastrointestinal Bleeding

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Outpatient

ACTIVE COMPARATOR

Other: Outpatient Management of Low-risk Patients

Inpatient

ACTIVE COMPARATOR

Other: Inpatient Management of Low-risk Patients

Interventions

Outpatient Management of Low-risk Patients 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

Outpatient

Inpatient Management of Low-risk Patients 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

Inpatient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Loren Laine, MD

  Yale University, Section of Digestive Disease

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 9, 2013
• Study Start: December 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 14, 2016

Record last verified: 2016-07

Locations

US (1)