In Vivo Study of Local Tranexamic Acid Concentrations Following Intra-Articular Administration in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Tranexamic acid concentrations in periarticular hematoma at 0.5, 1.5, 3, 6, and 9 hours following a standard intra-articular injection of 2 g of tranexamic acid
研究概览
简要总结
The goal of this observational study is to measure local tranexamic acid (TXA) concentrations following intra-articular administration in patients undergoing total knee arthroplasty. By evaluating its pharmacokinetic profile in the periarticular hematoma, the study will also assess the safety of topically administered TXA considering its cytotoxicity in healthy periarticular tissue. The main questions it aims to answer are:
- How does TXA concentration in periarticular hematoma change over time following intra-articular administration after TKA?
- Do local TXA concentrations after standard intra-articular dose of 2 g exceed the proposed cytotoxic levels, and for how long?
Participants will:
- Receive standard 2 g of TXA intra-articularly at the end of surgery as per the estabished hospital protocol
- Undergo intra-articular hematoma fluid sampling via a drainage catheter at 0.5, 1.5, 3, 6, and 9 hours postoperatively
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of advanced osteoarthritis of the knee joint
排除标准
- •known allergy to TXA
- •family history or past spontaneous thromboembolic event
- •pathological preoperative blood analysis
- •advanced heart failure (NYHA > 2)
- •ischemic heart disease
结局指标
主要结局
Tranexamic acid concentrations in periarticular hematoma at 0.5, 1.5, 3, 6, and 9 hours following a standard intra-articular injection of 2 g of tranexamic acid
时间窗: From the collection of samples after the total knee arthroplasty procedure to the analysis of hematoma samples within 2-3 weeks.
次要结局
未报告次要终点
