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

End Stage Renal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00157651
• Other study ID #: MCT-15226
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: June 16, 2008
• Start date: February 1999
• Est. completion date: March 2007

Study information

• Verified date: June 2008
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bleeding
• End Stage Renal Disease
• Hemorrhage
• Kidney Diseases
• Kidney Failure, Chronic
• Thrombosis

Intervention

Drug:
• warfarin
Daily oral warfarin with INR monitored weekly, adjusted to keep INR between 1.5 and 1.9
• placebo
matching placebo for warfarin, adjusted according to sham INR generated by unblinded warfarin monitor

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		monthly
Secondary	Blood flow rate and adequacy of dialysis.		monthly
Secondary	Major bleeding events.		monthly
Secondary	Death from any cause.		monthly