In Vivo Study of Local Tranexamic Acid Concentrations Following Intra-Articular Administration in Total Knee Arthroplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 40 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported