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

NCT ID: NCT00157651

Last Updated: 2008-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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

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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

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End Stage Renal Disease Thrombosis Bleeding

Keywords

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end stage renal disease thrombosis bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

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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

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Coumadin no other names

Eligibility Criteria

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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

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Hamilton Health Sciences Corporation

OTHER

Sponsor Role lead

Responsible Party

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McMaster University

Principal Investigators

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Alistair J Ingram, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor, Medicine

Catherine M Clase, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor, Medicine

Locations

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St. Joseph's Healthcare

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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MCT-15226

Identifier Type: -

Identifier Source: org_study_id