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

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ClinicalTrials.gov Identifier: NCT02005705
Recruitment Status : Terminated (Inadequate recruitment)
First Posted : December 9, 2013
Last Update Posted : July 14, 2016
Sponsor:
Information provided by (Responsible Party):
Loren Laine, Yale University

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.

Condition or disease Intervention/treatment Phase
Upper Gastrointestinal Bleeding Other: Outpatient Management of Low-risk Patients Other: Inpatient Management of Low-risk Patients Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of Outpatient vs. Inpatient Management of Low-risk Patients With Upper Gastrointestinal Bleeding.
Study Start Date : December 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005705


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

Responsible Party: Loren Laine, Professor of Medicine, Yale University
ClinicalTrials.gov Identifier: NCT02005705     History of Changes
Other Study ID Numbers: HIC 1307012373
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016

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