Status:
COMPLETED
Access II - Trial of Warfarin to Prevent Malfunction of Haemodialysis Catheters
Lead Sponsor:
Hamilton Health Sciences Corporation
Conditions:
End Stage Renal Disease
Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
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 7...
Eligibility Criteria
Inclusion
- Newly placed double-lumen hemodialysis catheter
Exclusion
- Major bleed within last 3 months
- Platelet count less than 50 x 10 9/L or current coagulopathy (most recent INR \> 1.5, not due to warfarin)
- Active peptic ulcer disease
- Anticipated need for invasive intervention within next 2 weeks
- Taking warfarin for an indication other than access prophylaxis
- Allergic to, or intolerant of, warfarin
- Pregnant
- Woman of child-bearing age who has not agreed to use an adequate method of birth control for the duration of the study
- Catheter likely needed for 2 weeks or less
- Patient previously took part in the study
- Patient has known aortic aneurysm of 6cm or greater
- Patients nephrologist has refused consent
- Patient has refused consent
Key Trial Info
Start Date :
February 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT00157651
Start Date
February 1 1999
End Date
March 1 2007
Last Update
June 17 2008
Active Locations (1)
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1
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6