NCT01508416已完成不适用
Study of Thrombin Generation During the 3 First Cycles of Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma: a Multicentric Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 5
- 主要终点
- change from baseline in Thrombin generation measure
研究概览
简要总结
Patients with Multiple Myeloma (MM) are at increased risk of venous thromboembolic event, especially in newly diagnosed patients and during induction treatment with thalidomide in combination with dexamethasone. This association was mainly heightened during the 3 first months of chemotherapy.
Several coagulation abnormalities have been described. Laboratory tests measuring the overall thrombophilic tendency might be useful to assess thrombosis risk.
The aim of this study is to compare thrombin generation by calibrated automated thrombogram during the 3 first cycles of chemotherapy in patients with newly diagnosed MM.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inscription to medical assurance
- •Patients who gave their written consent
- •Patients with newly diagnosed Multiple Myeloma required chemotherapy
排除标准
- •Patients with renal failure who need to undergo hemodialysis
- •Patients with indication for curative anticoagulant therapy
- •Patient with 3 month follow-up not possible
- •Patient with life expectancy < 6 month
结局指标
主要结局
change from baseline in Thrombin generation measure
时间窗: day 0
change from baseline in Thrombin generation measure
次要结局
- change from baseline in TFPI resistance measure(day 0)
- image-confirmed venous thromboembolic events(day 63)
- change from baseline in acquired protein S deficiency measure(day 0)
研究者
研究点 (5)
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