NCT02361294已完成不适用
Prospective Study to Generate Hypotheses About the Role of Platelets and Immature Platelets in the Pathogenesis of Idiopathic Venous Thromboses and Pulmonary Embolisms
Technical University of Munich1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2014年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Significantly increased proportion of immature platelets in patients with deep venous thrombosis and/or pulmonary embolism compared to the control.
研究概览
简要总结
The study is designed to evaluate the role of platelets and immature platelets in the ethiopathology of deep venous thrombosis and pulmonary embolism.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 是
入选标准
- •Patients with a newly diagnosed deep venous thrombosis and/or pulmonary embolism. The thrombembolism is idiopathic or caused by immobilisation.
- •Control: Patients that present with a suspicion of deep venous thrombosis which is excluded by duplex sonography.
排除标准
- •therapy with glycoprotein IIb/IIIa-antagonists within the last 10 days
- •therapy with antiplatelet drugs (ASA, Clopidogrel, Ticagrelor, Prasugrel, Dipyridamol)
- •preexisting anticoagulation
- •number of platelets < 100.000/µl
- •anemia (hematocrit < 35%, Hb < 10 g/dl)
- •age > 80 y or < 18 y
- •renal insufficiency GFR < 30 ml/min
- •hepatic impairment with an increased risk for bleeding or coagulopathy, or liver cirrhosis (≥ Child Pugh B)
- •intracranial or intracerebral bleeding within the last six months
- •intraspinal or intracerebral vascular anomalies
- •clinically relevant acute bleedings
- •malign disease
- •infections within the last 7 d
- •hematological, rheumatologic and autoimmune diseases
- •operations within the last six months
- •transfusion of rec celll concentrates within the last six months
- •transfusion of fresh frozen plasma or platelet concentrates within the last month
- •preexisting medication with CYP 3A4 inhibitors and inductors, p-glycoprotein inhibitors (Azol-Antimycotis, HIV protease-inhibitors)
- •hypersensitivity/contraindications for Rivaroxaban
- •pregnancy or lactation
- •thrombophilia
- •thrombocytopathy
结局指标
主要结局
Significantly increased proportion of immature platelets in patients with deep venous thrombosis and/or pulmonary embolism compared to the control.
时间窗: at time of diagnosis
次要结局
- Significantly higher values of platelet function in patients with deep venous thrombosis and/or pulmonary embolism compared to the control.(at time of diagnosis)
- A persistently increased proportion of immature platelets in patients with deep venous thrombosis and/or pulmonary embolism compared to the controls three months after diagnosis.(3 months after diagnosis)
研究者
研究点 (1)
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