NCT01031992已完成3 期
Efficacy of Tranexamic Acid Taken Orally in Patients With Hereditary Hemorrhagic Telangiectasia
University Hospital, Saarland1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2002年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Change of hemoglobin level within the phases.
研究概览
简要总结
Hereditary hemorrhagic telangiectasia (HHT, Rendu-Osler-Weber Syndrome) is associated with frequent nosebleeds in the majority of cases. Several reports in the literature support the use of antifibrinolytics like Tranexamic acid to reduce nosebleeds. The objectives of the study are to test if Tranexamic acid taken orally can
- improve anemia (lead to an increased hemoglobin level)
- reduce nosebleeds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •hereditary hemorrhagic telangiectasia with nosebleeds and desire to be treated.
排除标准
- •pregnant,
- •had an increased risk of thrombotic events (history or signs of cerebrovascular events, cardiac arrhythmias, biochemically increased coagulation parameters),
- •renal insufficiency,
- •a history of massive hematuria or defects of color vision.
研究组 & 干预措施
Group I
Experimental
First verum (3 times 1 g Tranexamic acid daily) for three months, than placebo for 3 months.
干预措施: Tranexamic acid first, than placebo (Drug)
Group II
Experimental
First placebo for 3 months, than verum for 3 months (3 times 1 g Tranexamic acid daily).
干预措施: First placebo, than Tranexamic acid. (Drug)
结局指标
主要结局
Change of hemoglobin level within the phases.
时间窗: Beginning and end of each 3 months period.
次要结局
- Mean epistaxis score (daily duration multiplied by mean subjective daily intensity)(Measured once a day during each 3 months period)
研究者
研究点 (1)
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