Bleeding, End Stage Renal Disease, Thrombosis
Conditions
Keywords
end stage renal disease, thrombosis, bleeding
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.
Interventions
DRUGwarfarin
Daily oral warfarin with INR monitored weekly, adjusted to keep INR between 1.5 and 1.9
DRUGplacebo
matching placebo for warfarin, adjusted according to sham INR generated by unblinded warfarin monitor
Sponsors
Hamilton Health Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Blood flow rate and adequacy of dialysis. | monthly |
| Major bleeding events. | monthly |
| Death from any cause. | monthly |
Countries
Canada
Outcome results
None listed