NCT00375076已完成3 期
Prevention of Venous Thrombosis in Cancer Patients: A Prospective, Randomized, Double-blind Study Comparing Two Different Dosages of Low-molecular Weight Heparin
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
In a prospective, randomized, double-blind trial, the effects of two different dosages of LMWH (5000 anti-Xa U od sc and 10 000 anti-Xa U od sc daily) on markers of hemostatic system and thrombin generation will be investigated in non-surgical cancer patients will be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
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
- •Patients (> 18 years) with active cancer and at least one of the following indications for thromboprophylaxis with LMWH:
- •Immobilization
- •History of VTE
- •Acute inflammation
- •Heart failure (NYHA class III or IV)
- •Respiratory failure
排除标准
- •Indication for LMWH or UFH at therapeutic dosages
- •Treatment with antithrombotics (vitamin K antagonists, acetylsalicylic acid, clopidogrel) for reasons other than prevention of VTE (e.g. atrial fibrillation, myocardial infarction)
- •Contraindication for the treatment with LMWH
- •Major surgery within the last 4 weeks; minor surgery within the last week
- •Thrombocytopenia (< 100.000/μl)
- •Prolonged prothrombin time
- •Prolonged activated partial thromboplastin time (aPTT)
- •History of heparin-induced thrombocytopenia
- •Bodyweight < 50 kg or > 100 kg
- •Renal insufficiency (creatinine > 2 mg/dl)
研究者
研究点 (2)
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