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

June 16, 2008 updated by: Hamilton Health Sciences Corporation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

170

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: monthly
monthly

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Investigators

  • Principal Investigator: Alistair J Ingram, MD, Associate Professor, Medicine
  • Principal Investigator: Catherine M Clase, MD, Associate Professor, Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1999

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 10, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

June 17, 2008

Last Update Submitted That Met QC Criteria

June 16, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCT-15226

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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