Warfarin in Preventing Blood Clots in Cancer Patients With Central Venous Catheters
- Conditions
- Thromboembolism
- Registration Number
- NCT00024297
- Lead Sponsor
- Cancer Research Campaign Clinical Trials Centre
- Brief Summary
RATIONALE: Warfarin may be effective in preventing the formation of blood clots in patients with central venous catheters.
PURPOSE: Randomized clinical trial to study the effectiveness of warfarin in preventing blood clots in cancer patients who have central venous catheters.
- Detailed Description
OBJECTIVES:
* Determine the utility of warfarin in reducing thrombosis rates in cancer patients with central venous catheters.
* Compare the thrombosis rates in patients treated with different warfarin dosing schedules.
* Compare the adverse events and survival of patients receiving or not receiving this drug.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to sclerosant potential of cytotoxic regimen (low vs high), site of placement of catheter (peripheral vs central), and duration of drug administration (brief infusion (under 24 hours) vs prolonged infusion (24 hours and over)). Patients are randomized to 1 of 3 arms.
* Arm I: Patients receive no warfarin.
* Arm II: Patients receive oral warfarin daily beginning 3 days before placement of central venous catheter (CVC) and continuing until CVC is removed or thrombosis occurs.
* Arm III: Patients receive oral warfarin as in arm II, with dose adjustment after CVC placement to achieve and maintain INR level.
Patients are followed at 12 months.
PROJECTED ACCRUAL: A total of 1,400 patients (400 in arm I, 700 in arm II, and 300 in arm III) will be accrued for this study within 2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (38)
Queen Elizabeth Hospital at University of Birmingham
🇬🇧Birmingham, England, United Kingdom
City Hospital - Birmingham
🇬🇧Birmingham, England, United Kingdom
Birmingham Heartlands and Solihull NHS Trust -Teaching
🇬🇧Birmingham, England, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, England, United Kingdom
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
🇬🇧Cambridge, England, United Kingdom
Cumberland Infirmary
🇬🇧Carlisle, England, United Kingdom
Cheltenham General Hospital
🇬🇧Cheltenham, England, United Kingdom
Essex County Hospital
🇬🇧Colchester, England, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, England, United Kingdom
Diana Princess of Wales Hospital
🇬🇧Grimsby, England, United Kingdom
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