Access II - Trial of Warfarin to Prevent Malfunction of Haemodialysis Catheters - Full Text View

Sponsor:	Hamilton Health Sciences Corporation
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00157651

Purpose

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	Intervention	Phase
End Stage Renal Disease Thrombosis Bleeding	Drug: warfarin Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Dialysis Kidney Failure

Drug Information available for: Warfarin Warfarin sodium Warfarin potassium

U.S. FDA Resources

Further study details as provided by McMaster University:

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. [ Time Frame: monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Blood flow rate and adequacy of dialysis. [ Time Frame: monthly ] [ Designated as safety issue: No ]
Major bleeding events. [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
Death from any cause. [ Time Frame: monthly ] [ Designated as safety issue: No ]

Enrollment:	170
Study Start Date:	February 1999
Study Completion Date:	March 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157651

Locations

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

Sponsors and Collaborators

Hamilton Health Sciences Corporation

Investigators

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

More Information

No publications provided

Responsible Party:	Dr. Alistair Ingram Professor of Medicine, McMaster University
ClinicalTrials.gov Identifier:	NCT00157651 History of Changes
Other Study ID Numbers:	MCT-15226
Study First Received:	September 8, 2005
Last Updated:	June 16, 2008
Health Authority:	Canada: Health Canada

Keywords provided by McMaster University:

end stage renal disease
thrombosis
bleeding

Additional relevant MeSH terms:

Hemorrhage
Kidney Diseases
Kidney Failure, Chronic
Thrombosis
Pathologic Processes
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012