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Completed

NCT Number: NCT00157651

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Warfarin

Drug

Daily oral warfarin with INR monitored weekly, adjusted to keep INR between 1.5 and 1.9

Other names: Coumadin

Placebo

Drug

matching placebo for warfarin, adjusted according to sham INR generated by unblinded warfarin monitor

Other names: no other names

Primary outcomes

  1. 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.

    Time frame: monthly

Secondary outcomes

  1. Blood flow rate and adequacy of dialysis.

    Time frame: monthly

  2. Major bleeding events.

    Time frame: monthly

  3. Death from any cause.

    Time frame: monthly

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Registry information

Official study 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

Important dates

Study start
1999
Primary completion
2007
Study completion
2007
First posted
Sep 12, 2005
Registry last updated
Jun 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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