Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-01-04 @ 7:49 PM
Study NCT ID:
NCT00157651
Status:
COMPLETED
Last Update Posted:
2008-06-17
First Post:
2005-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Access II - Trial of Warfarin to Prevent Malfunction of Haemodialysis Catheters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-03-20', 'releaseDate': '2017-01-31'}, {'resetDate': '2019-09-18', 'releaseDate': '2019-08-15'}, {'resetDate': '2023-01-06', 'releaseDate': '2022-04-09'}], 'estimatedResultsFirstSubmitDate': '2017-01-31'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014859', 'term': 'Warfarin'}], 'ancestors': [{'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-06-16', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-10', 'lastUpdatePostDateStruct': {'date': '2008-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time from catheter insertion to mechanical failure. This is defined as inability to aspirate or persistent blood flow less than 200mL/min after line reversal, patient repositioning and rotational manipulation of the catheter.', 'timeFrame': 'monthly'}], 'secondaryOutcomes': [{'measure': 'Blood flow rate and adequacy of dialysis.', 'timeFrame': 'monthly'}, {'measure': 'Major bleeding events.', 'timeFrame': 'monthly'}, {'measure': 'Death from any cause.', 'timeFrame': 'monthly'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['end stage renal disease', 'thrombosis', 'bleeding'], 'conditions': ['End Stage Renal Disease', 'Thrombosis', 'Bleeding']}, 'descriptionModule': {'briefSummary': 'This study examines whether low intensity, dose adjusted warfarin prolongs the time to mechanical failure of hemodialysis catheters without resulting in an unacceptable rate of bleeding.', 'detailedDescription': 'Patients with end-stage renal disease receiving or about to initiate hemodialysis are randomized to receive either adjusted dose warfarin to achieve an INR of 1.5-1.9 or adjusted dose placebo within 72 hours of hemodialysis catheter placement. The primary outcome is mechanical failure of the catheter, as outlined below.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly placed double-lumen hemodialysis catheter\n\nExclusion Criteria:\n\n* Major bleed within last 3 months\n* Platelet count less than 50 x 10 9/L or current coagulopathy (most recent INR \\> 1.5, not due to warfarin)\n* Active peptic ulcer disease\n* Anticipated need for invasive intervention within next 2 weeks\n* Taking warfarin for an indication other than access prophylaxis\n* Allergic to, or intolerant of, warfarin\n* Pregnant\n* Woman of child-bearing age who has not agreed to use an adequate method of birth control for the duration of the study\n* Catheter likely needed for 2 weeks or less\n* Patient previously took part in the study\n* Patient has known aortic aneurysm of 6cm or greater\n* Patients nephrologist has refused consent\n* Patient has refused consent'}, 'identificationModule': {'nctId': 'NCT00157651', 'briefTitle': 'Access II - Trial of Warfarin to Prevent Malfunction of Haemodialysis Catheters', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'A Double-Blind, Placebo Controlled, Randomized Trial of Low-Intensity Adjusted-Dose Warfarin for the Prevention of Mechanical Malfunction of Double-Lumen Haemodialysis Catheters', 'orgStudyIdInfo': {'id': 'MCT-15226'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Receiving warfarin', 'interventionNames': ['Drug: warfarin']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Receiving matching placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'warfarin', 'type': 'DRUG', 'otherNames': ['Coumadin'], 'description': 'Daily oral warfarin with INR monitored weekly, adjusted to keep INR between 1.5 and 1.9', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['no other names'], 'description': 'matching placebo for warfarin, adjusted according to sham INR generated by unblinded warfarin monitor', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8N 4A6', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Healthcare", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Alistair J Ingram, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor, Medicine'}, {'name': 'Catherine M Clase, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor, Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Alistair Ingram Professor of Medicine', 'oldOrganization': 'McMaster University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-01-31', 'type': 'RELEASE'}, {'date': '2017-03-20', 'type': 'RESET'}, {'date': '2019-08-15', 'type': 'RELEASE'}, {'date': '2019-09-18', 'type': 'RESET'}, {'date': '2022-04-09', 'type': 'RELEASE'}, {'date': '2023-01-06', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Catherine Clase, Associate professor, McMaster University'}}}}