NCT00199602已完成3 期
Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients : Phase III Randomised Study
University Hospital, Limoges1 个研究点 分布在 1 个国家目标入组 420 人开始时间: 1999年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Low molecular weight Heparin (LMWH) 2500 U anti-XA/day or Warfarine 1 mg/day during the first line of chemotherapy
研究概览
简要总结
This is a Phase III open-labed, multicenter, prospective, randomised study, and comparative 3-arms of 140 patients (i.e. 420 total patients).
Study period (date of first inclusion/last inclusion): 3 years Treatment period : 3 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First line chemotherapy for solid tumor with:
- •Metastatic disease or
- •Involved nodes or
- •Unresectable tumor
- •Indication for Implantable device for central venous access
- •Potential survival > 3 months
- •ECOG performance status 0 to 2 (WHO)
- •Age between 18 and 75 years.
- •Social security guaranteed
- •Normal laboratory assessments (platelets> 100000/mm3, TP 60%, spontaneous TCA with M/T<1.5, TGO and TGP < 2xN, serum creatinin<120µmol/l)
- •Informed consent signed
排除标准
- •Inability to understand informed consent or interfering with compliance for treatment or protocol Anti-coagulant treatment -related criteria
- •Acute infectious endocarditis
- •History related with heparin allergy or thrombopenia due to heparin
- •Uncontrolled high blood pressure (systolic blood pressure >180 mm Hg and/or diastolic blood pressure >110 mm Hg)
- •Hemorrhagic syndrome ongoing
- •Patient with platelet inhibitors treatment
- •Chronic, daily treatment with anti-coagulant therapy (LMWH or AVK), use as preventive or curative level
- •Patient with liver failure (TP<60%) or renal insufficiency (creatinin clearance< 20 ml/mn)
- •Women with pregnancy and lactating Pathology-related criteria
- •deep venous thrombosis history or pulmonary embolism (< 6 months)
- •Clinical suspicious of brain metastasis
研究组 & 干预措施
HBPM 2500 UI anti Xa in one subcutaneous injection per day
Experimental
干预措施: warfarine - low molecular heparin (Drug)
warfarine 1mg daily
Experimental
干预措施: warfarine - low molecular heparin (Drug)
结局指标
主要结局
Low molecular weight Heparin (LMWH) 2500 U anti-XA/day or Warfarine 1 mg/day during the first line of chemotherapy
时间窗: Day90
Evaluation of the prevalence of symptomatic or asymptomatic deep venous thrombosis in cancer patients with implantable device for central venous access with or without prophylaxis :
时间窗: Day90
次要结局
- - Overall survival in each group.(Day90)
- - Frequency of other symptomatic venous thromboembolic events between 3 groups.(J0, J1, J21, J42, J63 and J90)
- Comparison of thrombosis prophylaxis by LMWH with warfarin at low dose(Day90)
- -Costs in the 3 strategies(J90)
- - Tumoral response to chemotherapy in the 3 groups.(Day90)
- - Detection of asymptomatic thrombosis related to implantable device estimated by a systematic echo-doppler. -(Day90)
研究者
研究点 (1)
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