NCT00182104已完成4 期
An International Multi Centre Randomized Clinical Trial Of Anticoagulation In Children Following Fontan Procedures
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 13
- 主要终点
- Warfarin vs ASA in prevention of thrombosis 2 yrs after Fontan
研究概览
简要总结
Compare heparin/warfarin to ASA for thromboembolic prophylaxis in the first two years following Fontan procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Patient is scheduled to have a Fontan or modified Fontan procedure
排除标准
- •Requirement for long-term anticoagulation (e.g., prosthetic heart valve, active DVT)
- •Risk of significant bleeding or any other known medical contraindication to Heparin, Warfarin, or ASA.
- •Inability to supervise therapy due to social or geographical reasons.
- •Pregnancy or potential pregnancy during study period
结局指标
主要结局
Warfarin vs ASA in prevention of thrombosis 2 yrs after Fontan
次要结局
- Identify subpopulation of Fontan pts at high risk for TEs
- Determine high risk period for TEs in first 2 yrs post Fontan
研究者
研究点 (13)
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