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临床试验/NCT06876181
NCT06876181已完成不适用

In Vivo Study of Local Tranexamic Acid Concentrations Following Intra-Articular Administration in Total Knee Arthroplasty

Valdoltra Orthopedic Hospital1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年8月23日最近更新:
适应症

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

研究者

发起方
Valdoltra Orthopedic Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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