Thromboembolism Clinical Trial
Official title:
A Multicenter Prospective Randomized Controlled Trial of Thrombosis Prophylaxis With Warfarin in Cancer Patients With Central Venous Catheters
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.
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.
;
Primary Purpose: Supportive Care
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