NCT01167764撤回3 期
Effect of Tranexamic Acid on Prevention of Recurrence of Hemoptysis: Multicenter, Prospective, Randomized, Double-blind Phase 3 Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- the proportion of recurrence of hemoptysis
研究概览
简要总结
Hemoptysis is one of the serious complication of many pulmonary diseases. Upto now, there is no proven medical treatment in recurrence of hemoptysis. The investigators will conduct a randomized, placebo controlled trial of tranexamic acid, which can reduce the recurrence of hemoptysis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: >=20 and <=75
- •ER visit or admission for hemoptysis
- •no evidence of hemoptysis on screening
排除标准
- •anticoagulation treatment
- •Cr >= 2.0 mg/dL or urinary protein >= 2+ or who received renal replacement treatment
- •hepatic failure: total bilirubin >= 1.5 mg/dL or AST or ALT >= 1.5 of upper normal limit level
- •hypersensitivity to tranexamic acid
- •pregnant woman
- •fertile female who don't use contraception
研究组 & 干预措施
tranexamic acid
Active Comparator
tranexamic acid 250mg po 3 times/day for 1 months
干预措施: tranexamic acid, placebo (Drug)
placebo
Placebo Comparator
placebo po 3 times/day for 1 months
干预措施: tranexamic acid, placebo (Drug)
结局指标
主要结局
the proportion of recurrence of hemoptysis
时间窗: 6 month: 1months medication + 5months observation
次要结局
- time to recurrence(6 month: 1months medication + 5months observation)
研究者
研究点 (3)
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