Completed

NCT Number: NCT06876181

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

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

Completed

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Key information

Conditions

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

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Valdoltra Orthopaedic Hospital

Ankaran, Municipality of Ajdovščina, 6280, Slovenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

diagnosis of advanced osteoarthritis of the knee joint

Exclusion criteria

known allergy to TXA
family history or past spontaneous thromboembolic event
pathological preoperative blood analysis
advanced heart failure (NYHA > 2)
ischemic heart disease
epilepsy

Treatment and study plan

Pharmacokinetics of Intra-Articularly Administered TXA: Postoperative Concentration Dynamics in Periarticular Hematoma

Other

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.

Primary outcomes

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

Time frame: From the collection of samples after the total knee arthroplasty procedure to the analysis of hematoma samples within 2-3 weeks.

Sponsors and collaborators

Lead sponsor

Valdoltra Orthopedic Hospital