Fixed Dose Unfractionated Heparin for Initial Treatment of Venous Thromboembolism
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 866
- 试验地点
- 14
- 主要终点
- Symptomatic Venous Thromboembolism
研究概览
简要总结
FIDO was a multicentred randomized, open-label trial that compared fixed-dose UFH with fixed-dose LMWH for initial treatment of VTE. Patients were followed for 3 months during which they received warfarin (target INR 2.0-3.0).
详细描述
The general objective was to simplify and reduce the cost of treatment of acute venous thromboembolism (VTE).Specific objectives were to compare the efficacy, safety and cost effectiveness of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) when each is administered subcutaneously (sc), twice daily, in weight -adjusted, fixed doses; and to determine if the anticoagulant response (anti-Factor Xa heparin levels, APTT results) influence efficacy and safety of UFH and LMWH, independently of dose.
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
- •A diagnosis of acute venous thromboembolism (VTE,DVT and /or PE)
排除标准
- •Contraindication to subcutaneous (sc) route of administration (eg:shock (evidence of poor peripheral perfusion), major surgery within 48 hours)
- •Active Bleeding process
- •Comorbid condition limiting expected survival to less than 3 months
- •Current treatment with therapeutic dose of UFH, LMWH, danaparoid sodium, or a direct thrombin inhibitor for more than 48 hours
- •Currently on long term warfarin or heparin therapy
- •Allergy to heparin or history of heparin induced thrombocytopenia
- •Currently pregnant
- •Contraindication to contrast media (eg: allergy or creatinine >200 umol/L).
- •Currently enrolled or will be enrolled in a competing study
- •Geographically inaccessible for follow-up assessment
结局指标
主要结局
Symptomatic Venous Thromboembolism
Major Bleeding
Death
次要结局
- aXa ~6h after sc injection on 3rd day of treatment