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

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamilton Health Sciences Corporation
• Treatments: Warfarin

Criteria

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