Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT00182351
Status:
COMPLETED
Last Update Posted:
2006-09-08
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
D-Dimer Vs Serial Compression Ultrasound Study
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C036309', 'term': 'fibrin fragment D'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 810}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'completionDateStruct': {'date': '1999-07'}, 'lastUpdateSubmitDate': '2006-09-07', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2006-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'safety of withholding anticoagulants'}], 'secondaryOutcomes': [{'measure': 'deep vein thrombosis'}, {'measure': 'pulmonary embolism'}, {'measure': 'death'}]}, 'conditionsModule': {'keywords': ['deep vein thrombosis', 'd-dimer', 'serial compression ultrasound'], 'conditions': ['Deep Vein Thrombosis']}, 'referencesModule': {'references': [{'pmid': '15809460', 'type': 'RESULT', 'citation': 'Kearon C, Ginsberg JS, Douketis J, Crowther MA, Turpie AG, Bates SM, Lee A, Brill-Edwards P, Finch T, Gent M. A randomized trial of diagnostic strategies after normal proximal vein ultrasonography for suspected deep venous thrombosis: D-dimer testing compared with repeated ultrasonography. Ann Intern Med. 2005 Apr 5;142(7):490-6. doi: 10.7326/0003-4819-142-7-200504050-00007.'}]}, 'descriptionModule': {'briefSummary': 'To determine whether d-dimer testing can be used to simplify and reduce the costs of the diagnostic approach to patients with clinically suspected deep vein thrombosis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* first suspected deep vein thrombosis\n* no previous venous thromboembolism\n* referred to thromboembolism outpatient clinic\n\nExclusion Criteria:\n\n* comorbid condition limiting survival to less than six months\n* contraindication to venography (contrast allergy, etc.)\n* receiving long term warfarin therapy\n* receiving full dose heparin therapy for more than 48 hours\n* absence of symptoms during the five days immediately prior to presentation\n* symptoms of pulmonary embolism\n* pregnancy\n* geographic inaccessibility which precludes follow-up'}, 'identificationModule': {'nctId': 'NCT00182351', 'briefTitle': 'D-Dimer Vs Serial Compression Ultrasound Study', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Evaluation of the Safety, Efficacy and Cost-Effectiveness of Two Strategies for the Diagnosis of Deep Vein Thrombosis', 'orgStudyIdInfo': {'id': 'CTMG-1995-DDCUS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'D-dimer', 'type': 'PROCEDURE'}, {'name': 'Serial Compression Ultrasound', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8L 2X2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Health Sciences - Hamilton General Hospital', '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': 'Hamilton Health Sciences - Henderson Hospital', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Clive Kearon, MB', 'role': 'STUDY_CHAIR', 'affiliation': 'Hamilton Health Sciences and McMaster University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Health Canada', 'class': 'OTHER_GOV'}]}}}