Access II - Trial of Warfarin to Prevent Malfunction of Haemodialysis Catheters
Information source: Hamilton Health Sciences
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: End Stage Renal Disease; Thrombosis; Bleeding
Intervention: warfarin (Drug); placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Hamilton Health Sciences Official(s) and/or principal investigator(s):
Alistair J Ingram, MD, Principal Investigator, Affiliation: Associate Professor, Medicine
Catherine M Clase, MD, Principal Investigator, Affiliation: Associate Professor, Medicine
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.
Clinical Details
Official title: A Double-Blind, Placebo Controlled, Randomized Trial of Low-Intensity Adjusted-Dose Warfarin for the Prevention of Mechanical Malfunction of Double-Lumen Haemodialysis Catheters
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
Secondary outcome: Blood flow rate and adequacy of dialysis.Major bleeding events. Death from any cause.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
St. Joseph's Healthcare, Hamilton, Ontario L8N 4A6, Canada
Additional Information
Starting date: February 1999
Ending date: March 2007
Last updated: June 16, 2008
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