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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Yale University
Sponsor:
Information provided by (Responsible Party):
Loren Laine, Yale University
ClinicalTrials.gov Identifier:
NCT02005705
First received: December 3, 2013
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Upper Gastrointestinal Bleeding
Other: Outpatient Management of Low-risk Patients
Other: Inpatient Management of Low-risk Patients

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial of Outpatient vs. Inpatient Management of Low-risk Patients With Upper Gastrointestinal Bleeding.

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 242
Study Start Date: December 2013
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02005705

Contacts
Contact: Loren Laine, MD 203-937-3462 loren.laine@yale.edu

Locations
United States, Connecticut
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Loren Laine, MD Yale University, Section of Digestive Disease
  More Information

No publications provided

Responsible Party: Loren Laine, Professor of Medicine, Yale University
ClinicalTrials.gov Identifier: NCT02005705     History of Changes
Other Study ID Numbers: HIC 1307012373
Study First Received: December 3, 2013
Last Updated: December 6, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Hemorrhage
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014