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

NCT ID: NCT06876181

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-23
• Study Completion Date: 2024-09-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Recruited subjects with end-stage knee joint osteoarthritis

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

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ljubljana, Faculty of Medicine

OTHER

Sponsor Role: collaborator

Valdoltra Orthopedic Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Valdoltra Orthopaedic Hospital

Ankaran, Ajdovščina Municipality, Slovenia

Countries

Slovenia

Other Identifiers

J3-3067

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

J3-3067

Identifier Type: -

Identifier Source: org_study_id