Access II - Trial of Warfarin to Prevent Malfunction of Haemodialysis Catheters

A Double-Blind, Placebo Controlled, Randomized Trial of Low-Intensity Adjusted-Dose Warfarin for the Prevention of Mechanical Malfunction of Double-Lumen Haemodialysis Catheters

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.

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.

Inclusion Criteria:

• Newly placed double-lumen hemodialysis catheter

Exclusion Criteria:

• 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