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

NCT06876181 | Completed

• 1 other identifier: J3-3067
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Tranexamic acid; Intra-articular administration; topical administration; Local concentration; Elimination half-time

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Recruited subjects with end-stage knee joint osteoarthritis

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

Interventions

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.

Recruited subjects with end-stage knee joint osteoarthritis

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants were recruited from Valdoltra Orthopaedic Hospital between August 2022 and March 2023.

You may qualify if:

• diagnosis of advanced osteoarthritis of the knee joint

You may not qualify if:

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

Sponsors & Collaborators

• Valdoltra Orthopedic Hospital: lead
• University of Ljubljana, Faculty of Medicine: collaborator

Study Sites (1)

Valdoltra Orthopaedic Hospital

Ankaran, Ajdovščina Municipality, 6280, Slovenia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples of postoperative periarticular haematoma obtained via a drainage catheter inserted into the knee joint space.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: March 14, 2025
• Study Start: August 23, 2022
• Primary Completion: March 6, 2023
• Study Completion: September 30, 2024
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Begining 3 months and ending 1 year after the publication of results.

Locations

SL (1)