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

H

Hamilton Health Sciences (HHS)

Status and phase

Completed
Phase 3

Conditions

Thrombosis
End Stage Renal Disease
Bleeding

Treatments

Drug: warfarin
Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00157651
MCT-15226

Details and patient eligibility

About

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.

Full 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.

Enrollment

170 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

170 participants in 2 patient groups, including a placebo group

1
Active Comparator group
Description:
Receiving warfarin
Treatment:
Drug: warfarin
2
Placebo Comparator group
Description:
Receiving matching placebo
Treatment:
Drug: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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