NCT03606109已完成4 期
Reducing Hemarthrosis in Tibial Tubercle Osteotomy by the Administration of Intravenous Tranexamic Acid
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Perioperative Blood Loss
研究概览
简要总结
The purpose of the proposed study is to evaluate the effects of administering intravenous tranexamic acid (TXA) to patients undergoing high tibial osteotomy (HTO) and tibial tubercle osteotomy (TTO) to minimize hemarthrosis within the knee joint and post operative pain and swelling.
详细描述
Not Provided
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing TTO
- •Age 18-60
- •Willing and able to provide consent
排除标准
- •Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
- •Younger than 18 years of age
- •Older than 60 years of age
- •Any patient considered a vulnerable subject
- •Have bleeding or clotting disorder
- •Preoperative anticoagulation therapy
- •Abnormal coagulation profile
- •Renal disorder or insufficiency
- •Sickle cell disease
研究组 & 干预措施
High Tibial Osteotomy (HTO)
Active Comparator
干预措施: Tranexamic Acid (TXA) (Drug)
Tibial Tubercle Ostetomy (TTO)
Active Comparator
干预措施: Tranexamic Acid (TXA) (Drug)
结局指标
主要结局
Perioperative Blood Loss
时间窗: Perioperative, up to 2 hours
次要结局
- Score on Visual Analogue Scale (VAS) for Pain(Day 7)
研究者
研究点 (1)
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