Deep Venous Thrombosis. Long-Term Results After Treatment With Either Low-Molecular -Weight Heparin or Unfractionated Heparin. Examinations of the Venous System.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Clinical evaluation of chronic venous insufficiency (CVI) - (Postthrombotic Syndrome) based on internationally accepted criteria.
研究概览
简要总结
The purpose of the study was to evaluate efficacy and safety of the new acute treatment of deep venous thrombosis by use of low-molecular-weight heparin compared with standard treatment using unfractionated heparin, especially concerning long-term morbidity.
详细描述
Deep-venous thrombosis (DVT) remains a common clinical problem (annual incidence 0.10-0.16%) and long-term morbidity as chronic venous insufficience (CVI) in 10-30%.
As to recurrent DVT, initial treatment with Low-Molecular-Weight Heparin ( to-day's terminology Fractionated Heparin (FH)) and Unfractionated Heparin (UFH) has shown equal efficiency, whereas the efficacy concerning long-term morbidity has only more recently been published.
This study was initiated to compare the efficacy of UFH and FH concerning the incidence of CVI after symptomatic DVT at short-term and long-term follow-up.
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
- •First DVT with or without known risk factors except overt cancer
- •Second DVT more than two years after the first if the patient was without clinical signs of CVI.
排除标准
- •Contraindication to anticoagulation therapy
- •Candidate to thrombectomy with arterious-venous fistula or thrombolytic therapy
- •Known cancer at the time of the DVT diagnosis
- •Patients unable to cooperate for anticoagulation therapy or manage the tests.
研究组 & 干预措施
1
UFH: patients treated with unfractionated heparin
干预措施: unfractionated heparin (Drug)
2
FH: patients treated with low-molecular-weight (fractionated) heparin
干预措施: Tinzaparin (Leo) (Drug)
结局指标
主要结局
Clinical evaluation of chronic venous insufficiency (CVI) - (Postthrombotic Syndrome) based on internationally accepted criteria.
时间窗: Two years and 6 to 10 years
次要结局
未报告次要终点