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

NCT00157651 | Completed Phase 3 DMC

• 1 other identifier: MCT-15226
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease; Thrombosis; Bleeding

Keywords

end stage renal disease; thrombosis; bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Blood flow rate and adequacy of dialysis.

  monthly

• Major bleeding events.

  monthly

• Death from any cause.

  monthly

Study Arms (2)

1

ACTIVE COMPARATOR

Receiving warfarin

Drug: warfarin

2

PLACEBO COMPARATOR

Receiving matching placebo

Drug: placebo

Interventions

warfarin DRUG

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

Also known as: Coumadin

1

placebo DRUG

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

Also known as: no other names

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly placed double-lumen hemodialysis catheter

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Thrombosis; Hemorrhage

Interventions

Warfarin

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Alistair J Ingram, MD

  Associate Professor, Medicine

  PRINCIPAL INVESTIGATOR

• Catherine M Clase, MD

  Associate Professor, Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: February 1, 1999
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: June 17, 2008

Record last verified: 2008-06

Locations

CA (1)