In Vivo Study of Local Tranexamic Acid Concentrations Following Intra-Articular Administration in Total Knee Arthroplasty
March 9, 2025 updated by: Valdoltra Orthopedic Hospital
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
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
48
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ajdovscina
-
Ankaran, Ajdovscina, Slovenia, 6280
- Valdoltra Orthopaedic Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Participants were recruited from Valdoltra Orthopaedic Hospital between August 2022 and March 2023.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Recruited subjects with end-stage knee joint osteoarthritis
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome 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
Time Frame: From the collection of samples after the total knee arthroplasty procedure to the analysis of hematoma samples within 2-3 weeks.
|
From the collection of samples after the total knee arthroplasty procedure to the analysis of hematoma samples within 2-3 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 23, 2022
Primary Completion (Actual)
March 6, 2023
Study Completion (Actual)
September 30, 2024
Study Registration Dates
First Submitted
March 9, 2025
First Submitted That Met QC Criteria
March 9, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 9, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- J3-3067 (Other Grant/Funding Number: Slovenian Research Agency (ARRS))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All IPD collected throughout the trial
IPD Sharing Time Frame
Begining 3 months and ending 1 year after the publication of results.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.