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

Phase 3

Completed

• Conditions: Thrombosis; End Stage Renal Disease; Bleeding
• Interventions: Drug: placebo; Drug: warfarin

• Registration Number: NCT00157651
• Lead Sponsor: Hamilton Health Sciences Corporation

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

Study Timeline

• Study Start: 1999-02
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-10
• Study First Posted: 2005-09-12
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-16
• Last Update Posted: 2008-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	Receiving matching placebo
1	warfarin	Receiving warfarin

Primary Outcome Measures

Name	Time	Method
Time from catheter insertion to mechanical failure. This is defined as inability to aspirate or persistent blood flow less than 200mL/min after line reversal, patient repositioning and rotational manipulation of the catheter.	monthly

Secondary Outcome Measures

Name	Time	Method
Major bleeding events.	monthly
Death from any cause.	monthly
Blood flow rate and adequacy of dialysis.	monthly

Trial Locations

Locations (1)

St. Joseph's Healthcare; 🇨🇦 Hamilton, Ontario, Canada