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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00157651
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : June 17, 2008
Information provided by:
McMaster University

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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Thrombosis Bleeding Drug: warfarin Drug: placebo Phase 3

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  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : February 1999
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Coumadin
Placebo Comparator: 2
Receiving matching placebo
Drug: placebo
matching placebo for warfarin, adjusted according to sham INR generated by unblinded warfarin monitor
Other Name: no other names

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00157651

Canada, Ontario
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Principal Investigator: Alistair J Ingram, MD Associate Professor, Medicine
Principal Investigator: Catherine M Clase, MD Associate Professor, Medicine

Responsible Party: Dr. Alistair Ingram Professor of Medicine, McMaster University Identifier: NCT00157651     History of Changes
Other Study ID Numbers: MCT-15226
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: June 17, 2008
Last Verified: June 2008

Keywords provided by McMaster University:
end stage renal disease

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency