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

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Yale University

Status

Terminated

Conditions

Upper Gastrointestinal Bleeding

Treatments

Other: Outpatient Management of Low-risk Patients
Other: Inpatient Management of Low-risk Patients

Study type

Interventional

Funder types

Other

Identifiers

NCT02005705
HIC 1307012373

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

17 participants in 2 patient groups

Outpatient
Active Comparator group
Treatment:
Other: Outpatient Management of Low-risk Patients
Inpatient
Active Comparator group
Treatment:
Other: Inpatient Management of Low-risk Patients

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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