Phase IV, Randomized, Open-Label Trial Comparing Long-Term Subcutaneous Low-Molecular Weight Heparin With Oral Anticoagulant Therapy in the Treatment of Deep Venous Thrombosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 241
- 试验地点
- 2
- 主要终点
- Incidence of symptomatic recurrent venous thromboembolism
研究概览
简要总结
The purpose of this study is to evaluate whether low-molecular-weight heparin could be equally or more effective than oral anticoagulation in the long-term treatment of deep venous thrombosis.
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 a similar period of time in patients with proximal venous thrombosis.
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
- •Consecutive, symptomatic patients with a first or recurrent episode of acute proximal-vein thrombosis of the lower limbs.
- •either sex and over 18 years of age
- •referred to the Vascular Surgery Department of the hospital
- •onset of symptoms less than 2 weeks
- •documented by compression ultrasonography,
排除标准
- •received heparin, low-molecular-weight heparin or oral anticoagulant therapy for more than 2 days for the present disease
- •pulmonary embolism requiring thrombolytic therapy
- •Need of surgical thrombectomy or vena cava interruption
- •receiving oral anticoagulant treatment or antiplatelet agents for other conditions
- •contraindication to anticoagulant treatment (active bleeding, severe blood pressure or allergy to the study drugs)
- •platelet count lower than 100x103 /μl or hemoglobin concentration lower than 7 g/dl or history of heparin-associated thrombocytopenia
- •severe renal failure necessitating dialysis
- •pregnancy
- •lumbar puncture within the previous 24 hours
研究组 & 干预措施
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 for 1 weeks followed by acenocoumarol for 6 months
干预措施: acenocoumarol (Drug)
结局指标
主要结局
Incidence of symptomatic recurrent venous thromboembolism
时间窗: 12 months
次要结局
- Occurrence of major bleeding(6 month treatment interval)