Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-02-22 @ 7:03 AM
Study NCT ID:
NCT02005705
Status:
TERMINATED
Last Update Posted:
2016-07-14
First Post:
2013-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Trial of Outpatient vs. Inpatient Management of Low-risk Patients With Upper Gastrointestinal Bleeding.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'whyStopped': 'Inadequate recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-12', 'studyFirstSubmitDate': '2013-12-03', 'studyFirstSubmitQcDate': '2013-12-06', 'lastUpdatePostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of patients requiring intervention for UGIB (endoscopic therapy, blood transfusion, surgery, interventional radiology)', 'timeFrame': 'Within 7 days of the index presentation to the emergency room'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Upper Gastrointestinal Bleeding']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Blood Urea Nitrogen \\< 18.2 mg/dl\n2. Hemoglobin ≥ 13.0 g/dl for men and ≥ 12.0 g/dl for women\n3. Systolic blood pressure ≥ 110 mm Hg\n4. Heart rate \\< 100 beats/min\n\nExclusion Criteria:\n\n1. Inability to obtain informed consent\n2. Pregnancy\n3. History of liver disease\n4. History of heart failure\n5. Syncope that is temporally related to ongoing bleeding\n6. Melena\n7. Contraindication to proton pump inhibitor use\n8. Other conditions that necessitate inpatient evaluation.\n9. Inpatients with new onset of GI bleeding'}, 'identificationModule': {'nctId': 'NCT02005705', 'briefTitle': 'Randomized Trial of Outpatient vs. Inpatient Management of Low-risk Patients With Upper Gastrointestinal Bleeding.', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Randomized Trial of Outpatient vs. Inpatient Management of Low-risk Patients With Upper Gastrointestinal Bleeding.', 'orgStudyIdInfo': {'id': 'HIC 1307012373'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Outpatient', 'interventionNames': ['Other: Outpatient Management of Low-risk Patients']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Inpatient', 'interventionNames': ['Other: Inpatient Management of Low-risk Patients']}], 'interventions': [{'name': 'Outpatient Management of Low-risk Patients', 'type': 'OTHER', 'description': '* Labs will be obtained within 2-3 days of discharge from ED\n* Clinic visit will be scheduled within 3 days of discharge from ED\n* EGD will be scheduled within 7 days of discharge from ED\n* Phone follow-up at day 7 and 30', 'armGroupLabels': ['Outpatient']}, {'name': 'Inpatient Management of Low-risk Patients', 'type': 'OTHER', 'description': '* Labs will be obtained on day of discharge or day 2-3\n* EGD will be performed in the hospital\n* Phone follow-up at day 7 and 30', 'armGroupLabels': ['Inpatient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Loren Laine, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University, Section of Digestive Disease'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Loren Laine', 'investigatorAffiliation': 'Yale University'}}}}