Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-01-04 @ 5:13 PM
Study NCT ID:
NCT00149357
Status:
TERMINATED
Last Update Posted:
2017-03-23
First Post:
2005-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fetal Loss in Women With Unprovoked Thromboembolism (FLUTE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D005313', 'term': 'Fetal Death'}, {'id': 'D019851', 'term': 'Thrombophilia'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 239}}, 'statusModule': {'whyStopped': 'Funding withdrawn due to low enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-21', 'studyFirstSubmitDate': '2005-09-06', 'studyFirstSubmitQcDate': '2005-09-06', 'lastUpdatePostDateStruct': {'date': '2017-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['venous thromboembolism', 'VTE', 'thrombophilia', 'fetal loss'], 'conditions': ['Venous Thromboembolism', 'Fetal Death']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the risk of fetal loss in women with unprovoked venous thromboembolism (VTE) who do not have identifiable inherited thrombophilia compared with women who have the diagnosis of venous thromboembolism (VTE) excluded.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* At least 18 years of age\n* Symptomatic for unprovoked venous thromboembolism (deep vein thrombosis \\[DVT\\] or pulmonary embolism \\[PE\\])\n* At least one pregnancy not terminated intentionally\n\nExclusion Criteria:\n\n* Previous VTE in patients with current VTE excluded'}, 'identificationModule': {'nctId': 'NCT00149357', 'briefTitle': 'Fetal Loss in Women With Unprovoked Thromboembolism (FLUTE)', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Determining the Risk of Fetal Loss in Women With Unprovoked Venous Thromboembolism (VTE) Who Do NOT Have Identifiable Inherited Thrombophilia Compared With Women Who Have the Diagnosis of VTE Excluded', 'orgStudyIdInfo': {'id': 'CTMG-2005-FLUTE'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1, 2 ,3', 'description': 'Group 1 Women with unprovoked VTE and No Known Thrombophilia Group 2 Women who are investigated for VTE and are negative (Control) Group 3 Women with unprovoked VTE who have Thrombophilia', 'interventionNames': ['Other: Thrombophilia Testing']}], 'interventions': [{'name': 'Thrombophilia Testing', 'type': 'OTHER', 'description': 'TP testing in Group 1 and 3 only', 'armGroupLabels': ['1, 2 ,3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Monash Medical Centre', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'zip': 'L8L 2X2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton General Hospital', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L8N 3Z5', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster University Medical Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L8N 4A6', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Hospital", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L8V 1C3', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Henderson Research Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Huyen Tran, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'McMaster University; Department of Medicine'}, {'name': 'Jeffrey Ginsberg, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University; Department of Medicine'}, {'name': 'Clive Kearon, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University; Department of Medicine'}, {'name': 'Jim Julian, M.Math', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University; Dept. of Clinical Epidemiology & Biostatistics'}, {'name': 'Val Mueller, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University; Division of Obstetrics and Gynecology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}