Warfarin in Preventing Blood Clots in Cancer Patients With Central Venous Catheters

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multicenter Prospective Randomized Controlled Trial of Thrombosis Prophylaxis With Warfarin in Cancer Patients With Central Venous Catheters

Conditions
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Thromboembolism

Intervention / Treatment
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* Drug: warfarin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: warfarin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thromboembolism