NCT06876181

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 48 (actual)
• Sponsor: Valdoltra Orthopedic Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Local Concentration of Tranexamic Acid Following Intra-articular Administration in TKA

Interventions

Type	Name	Description
OTHER	Pharmacokinetics of Intra-Articularly Administered TXA: Postoperative Concentration Dynamics in Periarticular Hematoma	As part of the standard total knee arthroplasty procedure, participants receive a 2 g dose of tranexamic acid into the joint space after suturing the joint capsule. Before closing the joint capsule, a silicone drain is inserted into the joint space, through which periarticular hematoma samples are collected aseptically at 0.5, 1.5, 3, 6, and 9 hours post-application.

Timeline

• Start date: 2022-08-23
• Primary completion: 2023-03-06
• Completion: 2024-09-30
• First posted: 2025-03-14
• Last updated: 2025-03-14

Locations

1 site across 1 country: Slovenia