American Trial Using Tranexamic Acid in Thrombocytopenia (A-TREAT)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 3
- 主要终点
- Bleeding Within 30 Days
研究概览
简要总结
The purpose of this study is to evaluate the usefulness of antifibrinolytic therapy with tranexamic acid (TXA) in preventing bleeding in patients who are thrombocytopenic due to primary bone marrow disorders or chemotherapy, immunotherapy and/or radiation therapy.
详细描述
The purpose of this study is to conduct a prospective, randomized, blinded, placebo controlled trial to evaluate the usefulness of antifibrinolytic therapy with tranexamic acid in preventing bleeding in patients who are thrombocytopenic due to primary bone marrow disorders or chemotherapy, immunotherapy and/or radiation therapy. The results of this study will change practice by providing evidence as to whether or not TXA is effective and safe treatment when used as an adjunct to platelet transfusion therapy in the thrombocytopenic patient.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Tranexamic Acid (TXA)
IV or PO administered after meeting inclusion/exclusion criteria
干预措施: Tranexamic Acid (Drug)
Placebo
IV Normal Saline or PO placebo pills administered after meeting inclusion/exclusion criteria
干预措施: Placebo (Drug)
结局指标
主要结局
Bleeding Within 30 Days
时间窗: 30 days after activation of study drug
Proportion of patients with bleeding of WHO grade 2 or above, over the study period of 30 days after activation of study drug.
次要结局
- Number of Days Alive and Without WHO Grade 2 Bleeding(during the first 30 days post activation of study drug)
- Number of Platelet Transfusions(30 days after activation of study drug)
研究者
Susanne May
Professor, Biostatistics
University of Washington