NCT00365950已完成4 期
Clinical Trial of Two Durations of Warfarin Therapy in the Treatment of Deep Vein Thrombosis and/or Pulmonary Embolism
British Thoracic Society4 个研究点 分布在 1 个国家目标入组 2,400 人开始时间: 1999年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,400
- 试验地点
- 4
- 主要终点
- Death due to DVT/PE
研究概览
简要总结
To determine whether 3 months' anticoagulation is as good as or better than 6 months' for the treatment of DVT/PE
详细描述
Multi-centre trial involving 46 hospitals in the United Kingdom, with patients entered by 137 Consultant Physicians. Consenting patients were randomised in a central office to either 3 months' or 6 months' anticoagulation. Information on progress of the patients was requested by the co-ordinating office at 3 months, 6 months and 12 months. Outcomes were measured as death from DVT/PE, non-fatal extensions or recurrences of DVT/PE and major haemorrhages during and after anticoagulation.
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
- •Patients aged 18 years or more with suspected or proven DVT/PE whom the clinician intended to anticoagulate.
排除标准
- •DVT/PE severe enough to require thrombolysis or pulmonary embolectomy.
- •DVT/PE in the preceding 3 years.
- •Neoplasia diagnosed/treated within previous 3 years.
- •Pregnancy.
- •Known major thrombophilias.
- •Prolonged or continuous immobility or confinement to bed.
- •Previous allergy to heparin or warfarin.
- •Requirement for long-term anticoagulation.
- •Inability to give informed consent.
结局指标
主要结局
Death due to DVT/PE
Failures of resolution, extension or recurrence of DVT and/or PE during and after treatment.
Number of major haemorrhages.
次要结局
- Comparison of length of Hospital stay between those given unfractionated heparin and those given low molecular weight heparin.
研究者
研究点 (4)
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