Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-02-21 @ 4:43 AM
Study NCT ID:
NCT00549705
Status:
COMPLETED
Last Update Posted:
2009-09-17
First Post:
2007-10-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry of Hospitalized Patients Treated With Fondaparinux
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-15', 'studyFirstSubmitDate': '2007-10-24', 'studyFirstSubmitQcDate': '2007-10-25', 'lastUpdatePostDateStruct': {'date': '2009-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Venous Thromboembolism and Bleeding Events', 'timeFrame': '90 Days'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '30 Days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anticoagulation', 'Thrombosis', 'Bleeding', 'Clotting', 'Pulmonary Embolism', 'Deep Vein Thrombosis'], 'conditions': ['Deep Vein Thrombosis', 'Pulmonary Embolism']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.NATFonline.org', 'label': 'North American Thrombosis Forum (NATF)'}]}, 'descriptionModule': {'briefSummary': "Registry of Hospitalized patients at Brigham and Women's Hospital treated with Fondaparinux", 'detailedDescription': 'The use of antithrombotic agents in the hospital is the mainstay of therapy for the treatment or prophylaxis of venous thromboembolism (VTE) and acute coronary syndrome (ACS). Concern with the administration of heparins and risk for adverse sequelae has led to the development of newer, longer-acting agents. Fondaparinux offers once daily administration with only an extremely small risk of developing heparin induced thrombocytopenia.\n\nRecent data have further demonstrated the efficacy and safety of Fondaparinux in VTE and ACS, expanding its use in clinical practice. We aim to: 1) determine how Fondaparinux is being used in a "real life" clinical setting, a tertiary-care academic medical center (BWH), and 2) assess the associated clinical outcomes at 90 days after initiation of Fondaparinux.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'BWH hospitalized patients receiving Fondaparinux', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BWH hospitalized patients receiving Fondaparinux'}, 'identificationModule': {'nctId': 'NCT00549705', 'briefTitle': 'Registry of Hospitalized Patients Treated With Fondaparinux', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Registry of Hospitalized Patients Treated With Fondaparinux', 'orgStudyIdInfo': {'id': '2007-P-001294'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Samuel Z Goldhaber, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Samuel Z. Goldhaber, MD', 'oldOrganization': "Brigham and Women's Hospital"}}}}