NCT00024297已完成不适用
A Multicenter Prospective Randomized Controlled Trial of Thrombosis Prophylaxis With Warfarin in Cancer Patients With Central Venous Catheters
Cancer Research Campaign Clinical Trials Centre76 个研究点 分布在 1 个国家开始时间: 1999年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 76
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Supportive Care
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
- •Not specified
- •Not specified
- •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
- •Not specified
- •No prior enrollment on this study
- •No concurrent therapy that would interfere with study drug
- •No concurrent warfarin
排除标准
- 未提供
研究者
研究点 (76)
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