EUCTR2007-001048-32-FR进行中（未招募）不适用
Prospective, multicentre, open-label study evaluating Fondaparinux (1,5 mg/day) in venous thromboembolic events prevention in patients with renal impairment defined by a creatinin clearance between 20 and 50 ml/min and undergoing a major orthopaedic surgery (hip fracture, total hip replacement and total knee replacement)
CHU SAINT-ETIENNE0 个研究点开始时间: 2007年3月29日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patient affiliated with or a beneficiary of a social security category:
- •age > 18 years old,
- •requiring a major orthopaedic surgery (THR, TKR, HF) whatever procedure techniques are used, 1st indication or resumption,
- •requiring an antithrombotic prophylaxis,
- •presenting a renal impairment defined by a creatinin clearance (CrCl) between 20 and 50 ml/min calculated by Cockcroft and Gault’s formula,
- •having signed the inform consent form.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •contra-indications to fondaparinux,
- •history of heparin inducted thrombopenia (HIT),
- •history of venous thromboembolic event,
- •Haemorrhagic diathesis,
- •PT < 50 %, aPTT > 1,5 of control value, platelets < 100 G/l.
- •incapacity to understand protocol
研究者
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