Not Signed In -
Warfarin |
Coumadin; Jantoven |
Clinical Trial: Access II - Trial of Low-Intensity Adjusted-Dose Warfarin for the Prevention of Mechanical Malfunction of Double-Lumen Haemodialysis Catheters
This study is currently recruiting patients.
Verified by McMaster University September 2005
|
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| End Stage Renal Disease Thrombosis Bleeding | Drug: warfarin | Phase III |
MedlinePlus related topics: Kidney Failure; Vascular Diseases
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
Further Study Details:
Primary Outcomes: 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.
Secondary Outcomes: Blood flow rate and adequacy of dialysis.; Major bleeding events.; Death from any cause.
Expected Total Enrollment: 170
Secondary Outcomes: Blood flow rate and adequacy of dialysis.; Major bleeding events.; Death from any cause.
Expected Total Enrollment: 170
Study start: February 1999; Expected completion: January 2007
Last follow-up: December 2005; Data entry closure: April 2006
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00157651
Alistair J Ingram, MD 905-522-1155 Ext. 6151 ingrama@mcmaster.ca
Catherine M Clase, MD 905-522-1155 Ext. 6094 clase@mcmaster.ca
Catherine M Clase, MD 905-522-1155 Ext. 6094 clase@mcmaster.ca
Canada, Ontario
St. Joseph''''s Healthcare, Hamilton, Ontario, L8N 4A6, Canada; Recruiting
Dr. Alistair J Ingram, MD 905-522-1155 Ext. 6151 ingrama@mcmaster.ca
Catherine M Clase, MD 905-522-1155 Ext. 6094 clase@mcmaster.ca
Alistair J Ingram, MD, Principal Investigator
Catherine M Clase, MD, Principal Investigator
Catherine M Clase, MD 905-522-1155 Ext. 6094 clase@mcmaster.ca
Alistair J Ingram, MD, Principal Investigator
Catherine M Clase, MD, Principal Investigator
Study chairs or principal investigators
Alistair J Ingram, MD, Principal Investigator, Associate Professor, Medicine
Catherine M Clase, MD, Principal Investigator, Associate Professor, Medicine
More Information
Study ID Numbers: MCT-15226
Last Updated: September 10, 2005
Record first received: September 8, 2005
ClinicalTrials.gov Identifier: NCT00157651
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 10, 2005
Record first received: September 8, 2005
ClinicalTrials.gov Identifier: NCT00157651
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-09-13
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