Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-25 @ 4:48 PM
Study NCT ID:
NCT00182403
Status:
COMPLETED
Last Update Posted:
2017-06-07
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fixed Dose Heparin Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}], 'ancestors': [{'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 866}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2004-05'}, 'lastUpdateSubmitDate': '2017-06-06', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptomatic Venous Thromboembolism'}, {'measure': 'Major Bleeding'}, {'measure': 'Death'}], 'secondaryOutcomes': [{'measure': 'aXa ~6h after sc injection on 3rd day of treatment'}]}, 'conditionsModule': {'keywords': ['Unfractionated Heparin', 'Low Molecular Weight Heparin', 'Venous Thromboembolism', 'APTT', 'Treatment'], 'conditions': ['Venous Thromboembolism', 'Deep Vein Thrombosis', 'Pulmonary Embolism']}, 'referencesModule': {'references': [{'pmid': '16926353', 'type': 'RESULT', 'citation': 'Kearon C, Ginsberg JS, Julian JA, Douketis J, Solymoss S, Ockelford P, Jackson S, Turpie AG, MacKinnon B, Hirsh J, Gent M; Fixed-Dose Heparin (FIDO) Investigators. Comparison of fixed-dose weight-adjusted unfractionated heparin and low-molecular-weight heparin for acute treatment of venous thromboembolism. JAMA. 2006 Aug 23;296(8):935-42. doi: 10.1001/jama.296.8.935.'}]}, 'descriptionModule': {'briefSummary': 'FIDO was a multicentred randomized, open-label trial that compared fixed-dose UFH with fixed-dose LMWH for initial treatment of VTE. Patients were followed for 3 months during which they received warfarin (target INR 2.0-3.0).', 'detailedDescription': 'The general objective was to simplify and reduce the cost of treatment of acute venous thromboembolism (VTE).Specific objectives were to compare the efficacy, safety and cost effectiveness of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) when each is administered subcutaneously (sc), twice daily, in weight -adjusted, fixed doses; and to determine if the anticoagulant response (anti-Factor Xa heparin levels, APTT results) influence efficacy and safety of UFH and LMWH, independently of dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A diagnosis of acute venous thromboembolism (VTE,DVT and /or PE)\n\nExclusion Criteria:\n\n* Contraindication to subcutaneous (sc) route of administration (eg:shock (evidence of poor peripheral perfusion), major surgery within 48 hours)\n* Active Bleeding process\n* Comorbid condition limiting expected survival to less than 3 months\n* Current treatment with therapeutic dose of UFH, LMWH, danaparoid sodium, or a direct thrombin inhibitor for more than 48 hours\n* Currently on long term warfarin or heparin therapy\n* Allergy to heparin or history of heparin induced thrombocytopenia\n* Currently pregnant\n* Contraindication to contrast media (eg: allergy or creatinine \\>200 umol/L).\n* Currently enrolled or will be enrolled in a competing study\n* Geographically inaccessible for follow-up assessment'}, 'identificationModule': {'nctId': 'NCT00182403', 'briefTitle': 'Fixed Dose Heparin Study', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Fixed Dose Unfractionated Heparin for Initial Treatment of Venous Thromboembolism', 'orgStudyIdInfo': {'id': 'CTMG-2005-FIDO'}, 'secondaryIdInfos': [{'id': '#NA3640'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'UFH 250 U/kg or LMWH 100 U/kg sc twice daily', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8L 2X2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Health Sciences-General Campus', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L8N 3Z5', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamlton Health Sciences -McMaster Campus', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L8N 4A6', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Healthcare Centre", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L8V 1C3', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Health Sciences-Henderson Campus', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'H3G 1A4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University Health Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHA Pavillon du Saint-Sacrement', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland Hospital', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'city': 'Otahuhu', 'country': 'New Zealand', 'facility': 'Middlemore', 'geoPoint': {'lat': -36.9382, 'lon': 174.84019}}], 'overallOfficials': [{'name': 'Clive Kearon, MB Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hamiton Health Sciences'}, {'name': 'Jim Julian, MMath', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster-Dept. of Clinical Epidemiology &Biostatistics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Heart and Stroke Foundation of Ontario', 'class': 'OTHER'}]}}}