Local Concentration of Tranexamic Acid Following Intra-articular Administration in TKA
Conditions
Keywords
Tranexamic acid, Intra-articular administration, topical administration, Local concentration, Elimination half-time
Brief 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
Interventions
OTHERPharmacokinetics 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.
Sponsors
University of Ljubljana, Faculty of Medicine
Valdoltra Orthopedic Hospital
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | From the collection of samples after the total knee arthroplasty procedure to the analysis of hematoma samples within 2-3 weeks. |
Countries
Slovenia
Outcome results
None listed