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Sponsored by: |
Hamilton Health Sciences |
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Information provided by: | McMaster University |
ClinicalTrials.gov Identifier: | NCT00157651 |
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.
Condition | Intervention | Phase |
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End Stage Renal Disease Thrombosis Bleeding |
Drug: warfarin Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Placebo Controlled, Randomized Trial of Low-Intensity Adjusted-Dose Warfarin for the Prevention of Mechanical Malfunction of Double-Lumen Haemodialysis Catheters |
Enrollment: | 170 |
Study Start Date: | February 1999 |
Study Completion Date: | March 2007 |
Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Receiving warfarin
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Drug: warfarin
Daily oral warfarin with INR monitored weekly, adjusted to keep INR between 1.5 and 1.9
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2: Placebo Comparator
Receiving matching placebo
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Drug: placebo
matching placebo for warfarin, adjusted according to sham INR generated by unblinded warfarin monitor
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
St. Joseph's Healthcare | |
Hamilton, Ontario, Canada, L8N 4A6 |
Principal Investigator: | Alistair J Ingram, MD | Associate Professor, Medicine |
Principal Investigator: | Catherine M Clase, MD | Associate Professor, Medicine |
Responsible Party: | McMaster University ( Dr. Alistair Ingram Professor of Medicine ) |
Study ID Numbers: | MCT-15226 |
Study First Received: | September 8, 2005 |
Last Updated: | June 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00157651 History of Changes |
Health Authority: | Canada: Health Canada |
end stage renal disease thrombosis bleeding |
Renal Insufficiency Anticoagulants Kidney Failure, Chronic Vascular Diseases Warfarin Hemorrhage Thrombosis |
Embolism and Thrombosis Urologic Diseases Renal Insufficiency, Chronic Embolism Kidney Diseases Kidney Failure |
Renal Insufficiency Anticoagulants Hematologic Agents Kidney Failure, Chronic Vascular Diseases Warfarin Pharmacologic Actions Thrombosis |
Embolism and Thrombosis Urologic Diseases Renal Insufficiency, Chronic Therapeutic Uses Cardiovascular Diseases Kidney Diseases Kidney Failure |