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

Valdoltra Orthopedic Hospital

Status

Completed

Conditions

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

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT06876181

J3-3067 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Enrollment

48 patients

Sex

All

Ages

40 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria