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

Hamilton Health Sciences (HHS)

Status and phase

Completed

Phase 3

Conditions

Thrombosis

End Stage Renal Disease

Bleeding

Treatments

Drug: warfarin

Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00157651

MCT-15226

Details and patient eligibility

About

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.

Full 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 72 hours of hemodialysis catheter placement. The primary outcome is mechanical failure of the catheter, as outlined below.

Enrollment

170 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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