Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-03-09 @ 4:02 PM
Study NCT ID:
NCT03613402
Status:
WITHDRAWN
Last Update Posted:
2023-02-21
First Post:
2018-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BRAVO - Betrixaban Registry Using Real Time Observations in Acute Medical Illness to Assess Venous Thrombosis and Bleeding Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Due to slow enrollment.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-17', 'studyFirstSubmitDate': '2018-07-19', 'studyFirstSubmitQcDate': '2018-08-01', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thrombotic Events at 45 days: VTE, MI, Stroke, Transient ischemic attack (TIA)', 'timeFrame': '45 days', 'description': 'Thrombotic Events at 45 days: VTE, MI, Stroke, TIA'}], 'secondaryOutcomes': [{'measure': 'Bleeding rates at 45 days', 'timeFrame': '45 days', 'description': 'Bleeding rates at 45 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Venous Thromboses']}, 'descriptionModule': {'briefSummary': 'Part 1 - Evaluate the real-world implementation of extended prophylaxis with betrixaban in the acutely ill hospitalized medical population Part 2 - Describe patterns of Venous thromboembolism (VTE) prophylaxis in acutely ill medical patients who qualify for extended VTE prophylaxis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Acutely ill medical patients, hospitalized, prescribed therapy for VTE prophylaxis and who would qualify for extended prophylaxis (whether or not they receive prophylaxis).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Part 1 -\n\n1. Hospitalized acutely ill medical patient\n2. Patient prescribed betrixaban\n3. Signed informed consent\n\nPart 2 -\n\n1. Hospitalized acutely ill medical patient\n2. Patient prescribed betrixaban OR must satisfy criteria a and b:\n\n 1. Moderately or severely restricted immobility: patient restricted to bed for at least 24 hours (severe) or restricted to bed for at least 12 hours (moderate) during their hospitalization\n 2. At least One additional risk factor:\n\nAge \\> 70 years D-dimer \\> 2x institutional Upper Limit of Normal (ULN) Obesity: Body mass index (BMI) \\> 30 kg/m2) History of pulmonary embolism (PE) or deep venous thrombosis (DVT) Active cancer (diagnosed, treated, or progressing in the past 6 months) History of thrombophilia Recent trauma or surgery (within 30 days prior to admission) Ongoing hormonal treatment ICU stay 3. Signed informed consent\n\nExclusion Criteria:\n\n* Part 1 - 1. High bleeding risk - any of the following:\n\n 1. Patient on dialysis\n 2. Low platelet count (\\<50 per 109/L)\n 3. Known bleeding disorder (congenital or acquired)\n 4. Liver disease prohibitive to anticoagulation\n 5. Bleeding within last 30 days\n 6. Use of Dual Anti-Platelet Therapy (DAPT)\n\nPart 2\n\n1. Patients who are on another oral anticoagulant (OAC) for any reason at the time of hospitalization and will remain on it\n2. Condition requiring use of OAC at admission, other than VTE prophylaxis (eg, acute VTE at admission)\n3. High bleeding risk any of the following:\n\n 1. Patient on dialysis\n 2. Low platelet count (\\<50 per 109/L)\n 3. Known bleeding disorder (congenital or acquired)\n 4. Liver disease prohibitive to anticoagulation\n 5. Bleeding within last 30 days\n 6. Use of Dual Anti-Platelet Therapy (DAPT)'}, 'identificationModule': {'nctId': 'NCT03613402', 'briefTitle': 'BRAVO - Betrixaban Registry Using Real Time Observations in Acute Medical Illness to Assess Venous Thrombosis and Bleeding Outcomes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alexion Pharmaceuticals, Inc.'}, 'officialTitle': 'BRAVO - Betrixaban Registry Using Real Time Observations in Acute Medical Illness to Assess Venous Thrombosis and Bleeding Outcomes', 'orgStudyIdInfo': {'id': '18-025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Patients at risk of VTE who are prescribed betrixaban to prevent VTE'}, {'label': 'Cohort 2', 'description': 'Patients at risk of VTE who are prescribed betrixaban or other VTE prophylaxis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Durham', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Portola Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}