Back to resultsAccess II - Trial of Warfarin to Prevent Malfunction of Haemodialysis Catheters
Primary Purpose
End Stage Renal Disease, Thrombosis, Bleeding
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
warfarin
placebo
Sponsored by
About this trial
This is an interventional prevention trial for End Stage Renal Disease focused on measuring end stage renal disease, thrombosis, bleeding
Eligibility 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
Sites / Locations
- St. Joseph's Healthcare
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Receiving warfarin
Receiving matching placebo
Outcomes
Primary Outcome Measures
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 Measures
Blood flow rate and adequacy of dialysis.
Major bleeding events.
Death from any cause.
Full Information
NCT ID
NCT00157651
First Posted
September 8, 2005
Last Updated
June 16, 2008
Sponsor
Hamilton Health Sciences Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00157651
Brief Title
Access II - Trial of Warfarin to Prevent Malfunction of Haemodialysis Catheters
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 Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
February 1999 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hamilton Health Sciences Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Thrombosis, Bleeding
Keywords
end stage renal disease, thrombosis, bleeding
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Receiving warfarin
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Receiving matching placebo
Intervention Type
Drug
Intervention Name(s)
warfarin
Other Intervention Name(s)
Coumadin
Intervention Description
Daily oral warfarin with INR monitored weekly, adjusted to keep INR between 1.5 and 1.9
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
no other names
Intervention Description
matching placebo for warfarin, adjusted according to sham INR generated by unblinded warfarin monitor
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Blood flow rate and adequacy of dialysis.
Time Frame
monthly
Title
Major bleeding events.
Time Frame
monthly
Title
Death from any cause.
Time Frame
monthly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alistair J Ingram, MD
Organizational Affiliation
Associate Professor, Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Catherine M Clase, MD
Organizational Affiliation
Associate Professor, Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Access II - Trial of Warfarin to Prevent Malfunction of Haemodialysis Catheters
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