Long Term Subcutaneous Tinzaparin Compared With Tinzaparin and Oral Anticoagulants in the Treatment of the Acute Pulmonary Embolism
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 4
- 主要终点
- Feasibility of the secondary prophylaxis of pulmonary embolism with tinzaparin
研究概览
简要总结
The purpose of this study is to evaluate the feasibility of the long-term treatment of pulmonary embolism with tinzaparin compared to oral anticoagulants.
详细描述
The open-label prospective randomized clinical trial compares subcutaneous LMWH (tinzaparin) administered for 6 months versus initial treatment using subcutaneous LMWH followed by oral anticoagulants given for 6 months in patients with acute venous thrombosis.
To evaluate the direct and indirect cost of each treatment regimen in a rural population environment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Symptomatic pulmonary embolism patients confirmed by:
- •High probability ventilation/perfusion lung scan according to the PIOPED criteria
- •Spiral chest computed tomography, or
- •Pulmonary arteriography
- •Aged 18 years or above, of either sex
- •The patient must provide signed informed consent
- •Patients will be agreed for receiving ambulatory anticoagulant treatment
排除标准
- •Massive pulmonary embolism
- •Allergy to heparin, other components of Tinzaparin or acenocoumarol
- •Previous thrombocytopenia induced by heparin
- •Thrombocytopenia < 100000/mm3
- •History/signs/symptoms of congenital bleeding disorder
- •Life expectancy less than 90 days
- •Unfractioned heparin anticoagulation for more than 36 hours prior enrollment
- •Inability to participate in the home tinzaparin program
- •Clinical overt gastrointestinal blood loss due to peptic ulcer, intestinal tumours, oesophagitis or diverticulosis
- •Hemoglobin lower than 7 g/dL or Creatinin > 3mg/dL
- •Cerebral-vascular accident
- •Cerebral, medullary and ophthalmological surgery
研究组 & 干预措施
acenocoumarol
tinzaparin followed by acenocoumarol for 6 months
干预措施: acenocoumarol (Drug)
tinzaparin
tinzaparin (innohep®)subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months
干预措施: tinzaparin (Drug)
acenocoumarol
tinzaparin followed by acenocoumarol for 6 months
干预措施: tinzaparin (Drug)
结局指标
主要结局
Feasibility of the secondary prophylaxis of pulmonary embolism with tinzaparin
时间窗: 6 months
次要结局
- direct and indirect cost of each treatment regimen(6 months)
- Major haemorrhagic events(6 months)