NCT00157651

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• End Stage Renal Disease
• Thrombosis
• Bleeding

Interventions

Type	Name	Description
DRUG	warfarin	Daily oral warfarin with INR monitored weekly, adjusted to keep INR between 1.5 and 1.9
DRUG	placebo	matching placebo for warfarin, adjusted according to sham INR generated by unblinded warfarin monitor

Timeline

• Start date: 1999-02-01
• Primary completion: 2007-03-01
• Completion: 2007-03-01
• First posted: 2005-09-12
• Last updated: 2008-06-17

Locations

1 site across 1 country: Canada