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

NCT ID: NCT00157651

Last Updated: 2008-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-02-28
• Study Completion Date: 2007-03-31

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.

Conditions

End Stage Renal Disease; Thrombosis; Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

1

Receiving warfarin

Group Type: ACTIVE_COMPARATOR

warfarin

Intervention Type: DRUG

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

2

Receiving matching placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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

Interventions

warfarin

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

Intervention Type: DRUG

placebo

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

Intervention Type: DRUG

Other Intervention Names

Coumadin; no other names

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: lead

Responsible Party

McMaster University

Principal Investigators

Alistair J Ingram, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor, Medicine

Catherine M Clase, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor, Medicine

Locations

St. Joseph's Healthcare

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

MCT-15226

Identifier Type: -

Identifier Source: org_study_id