Local Concentration of Tranexamic Acid Following Intra-articular Administration in TKANCT06876181
In Vivo Study of Local Tranexamic Acid Concentrations Following Intra-Articular Administration in Total Knee Arthroplasty
An observational study of Local Concentration of Tranexamic Acid Following Intra-articular Administration in TKA, run by Valdoltra Orthopedic Hospital at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Local Concentration of Tranexamic Acid Following Intra-articular Administration in TKA
- What is being tested?
- Pharmacokinetics of Intra-Articularly Administered TXA: Postoperative Concentration Dynamics in Periarticular Hematoma
- Type of treatment
- Pill or oral medicine
- How many people
- 48 participants
- Where
- 1 siteSlovenia
- Study dates
- 23 Aug 2022to 30 Sep 2024
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants were recruited from Valdoltra Orthopaedic Hospital between August 2022 and March 2023.
Who may be able to join
- diagnosis of advanced osteoarthritis of the knee joint
Who cannot join
- known allergy to TXA
- family history or past spontaneous thromboembolic event
- pathological preoperative blood analysis
- advanced heart failure (NYHA > 2)
- ischemic heart disease
- epilepsy
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
Valdoltra Orthopaedic Hospital
Ankaran, Municipality of Ajdovščina, 6280
About this study
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?
Read more
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
- Being tested
- Pharmacokinetics of Intra-Articularly Administered TXA: Postoperative Concentration Dynamics in Periarticular Hematoma
- Keywords
- Tranexamic acid, Intra-articular administration, topical administration, Local concentration, Elimination half-time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacokinetics of Intra-Articularly Administered TXA: Postoperative Concentration Dynamics in Periarticular HematomaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Recruited subjects with end-stage knee joint osteoarthritis | Not described Receives: Other: Pharmacokinetics of Intra-Articularly Administered TXA: Postoperative Concentration Dynamics in Periarticular Hematoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From the collection of samples after the total knee arthroplasty procedure to the analysis of hematoma samples within 2-3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start23 Aug 2022
- Primary completion6 Mar 2023
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local Concentration of Tranexamic Acid Following Intra-articular Administration in TKAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valdoltra Orthopedic Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana, Faculty of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876181
- Sponsor's protocol ID
- J3-3067
- Other IDs
- J3-3067
- Status last verified
- Mar 2025
- First submitted
- 9 Mar 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the trial