A Multicenter Prospective Randomized Controlled Trial of Thrombosis Prophylaxis With Warfarin in Cancer Patients With Central Venous Catheters
16 Years
N/A
Both
Thromboembolism
Trial Information
A Multicenter Prospective Randomized Controlled Trial of Thrombosis Prophylaxis With Warfarin in Cancer Patients With 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed cancer
- Planned placement of central venous catheter (CVC) for administration of chemotherapy
- No use of CVC for additional purposes except for antibiotic therapy or blood
products
PATIENT CHARACTERISTICS:
Age:
- 16 and over
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 2,000/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin at least 10 g/dL
- No congenital bleeding disorders
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No contraindication to warfarin
- No anatomic lesions that bleed (e.g., duodenal ulcers)
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No prior enrollment on this study
- No concurrent therapy that would interfere with study drug
- No concurrent warfarin
Type of Study:
Interventional
Study Design:
Primary Purpose: Supportive Care
Principal Investigator
Annie Young
Investigator Role:
Study Chair
Investigator Affiliation:
University Hospital Birmingham
Authority:
United States: Federal Government
Study ID:
CDR0000068909
NCT ID:
NCT00024297
Start Date:
October 1999
Completion Date:
Related Keywords:
- Thromboembolism
- thromboembolism
- Thromboembolism
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