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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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End Stage Renal Disease, Thrombosis, Bleeding

Intervention / Treatment
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* Drug: warfarin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Receiving warfarin | Drug: warfarin<br>* Daily oral warfarin with INR monitored weekly, adjusted to keep INR between 1.5 and 1.9<br>* Other names: Coumadin;|
| Placebo Comparator: 2<br>Receiving matching placebo | Drug: placebo<br>* matching placebo for warfarin, adjusted according to sham INR generated by unblinded warfarin monitor<br>* Other names: no other names;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood flow rate and adequacy of dialysis. |  | monthly | 
| Major bleeding events. |  | monthly | 
| Death from any cause. |  | monthly | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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end stage renal disease, thrombosis, bleeding