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| ID | Type | Description | Link |
|---|---|---|---|
| J3-3067 | Other Grant/Funding Number | Slovenian Research Agency (ARRS) |
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| Name | Class |
|---|---|
| University of Ljubljana, Faculty of Medicine | OTHER |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recruited subjects with end-stage knee joint osteoarthritis |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | 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 | From the collection of samples after the total knee arthroplasty procedure to the analysis of hematoma samples within 2-3 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants were recruited from Valdoltra Orthopaedic Hospital between August 2022 and March 2023.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valdoltra Orthopaedic Hospital | Ankaran | Municipality of Ajdovščina | 6280 | Slovenia |
All IPD collected throughout the trial
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Begining 3 months and ending 1 year after the publication of results.
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Samples of postoperative periarticular haematoma obtained via a drainage catheter inserted into the knee joint space.
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