Plasma Concentrations of Intraosseous Versus Intravenous Tranexamic Acid in Joint Arthroplasty
Summary
This prospective randomized controlled trial aims to compare the pharmacokinetic profiles of intraosseous and intravenous tranexamic acid administration in patients undergoing primary total joint arthroplasty. Eligible patients undergoing total hip or total knee arthroplasty will be randomly assigned to receive tranexamic acid either through intraosseous injection or intravenous injection at a dose of 15 mg/kg. Blood samples will be collected at predefined time points to evaluate plasma concentrations and pharmacokinetic characteristics of tranexamic acid. Secondary outcomes include coagulation function, intraoperative blood loss, transfusion rate, and hemoglobin changes. The study aims to provide evidence regarding the pharmacokinetic characteristics and clinical feasibility of intraosseous tranexamic acid administration in joint arthroplasty.
Timeline
- Start
- 2026-05-27
- Primary completion
- 2026-06-03
- Completion
- 2026-12-30
Publications
- Results Tantavisut S, Artykbay S, Tangwiwat P, Susantitaphong P. Topical tranexamic acid in hip and knee surgery: a meta-analysis of randomized-controlled trials. EFORT Open Rev. 2025 Jul 1;10(7):454-465. doi: 10.1530/EOR-2024-0152.
- Results Yoon U, Beausang D, Elia E, Torjman M, Mojica J, Purtill J, Nazarian D, Courtney PM, Kang Y. The effect of tranexamic acid on blood coagulation in primary total hip arthroplasty using rotational thromboelastometry: a randomized controlled trial. EClinicalMedicine. 2025 Jul 21;86:103374. doi: 10.1016/j.eclinm.2025.103374. eCollection 2025 Aug.
- Results DeFrancesco CJ, Reichel JF, Gbaje E, Popovic M, Freeman C, Wong M, DeMeo D, Liu J, Gonzalez Della Valle A, Ranawat A, Cross M, Sculco PK, Haskins S, Kim D, Maalouf D, Kirksey M, Jules-Elysee K, Soffin EM, Kumar K, Beathe J, Figgie M, Inglis A Jr, Garvin S, Alexiades M, DelPizzo K, Russell LA, Sideris A, Saleh J, Zhong H, Memtsoudis SG. Effectiveness of oral versus intravenous tranexamic acid in primary total hip and knee arthroplasty: a randomised, non-inferiority trial. Br J Anaesth. 2023 Feb;130(2):234-241. doi: 10.1016/j.bja.2022.11.003. Epub 2022 Dec 14.
- Results Mukasa F, Baba T, Hayashi K, Watari T, Ishijima M. Effects of preoperative systemic administration of tranexamic acid alone on postoperative inflammation and pain in total hip arthroplasty: a retrospective cohort study. Arthroplasty. 2025 Jul 4;7(1):35. doi: 10.1186/s42836-025-00320-3.
- Results Jovanovic G, Lukic-Sarkanovic M, Lazetic F, Tubic T, Lendak D, Uvelin A. The Effect of Intravenous Tranexamic Acid on Perioperative Blood Loss, Transfusion Requirements, Verticalization, and Ambulation in Total Knee Arthroplasty: A Randomized Double-Blind Study. Medicina (Kaunas). 2024 Jul 21;60(7):1183. doi: 10.3390/medicina60071183.
- Results Wilde JM, Copp SN, Ezzet KA, Rosen AS, Walker RH, McCauley JC, Evans AS, Bugbee WD. No Difference in Blood Loss and Risk of Transfusion Between Patients Treated with One or Two Doses of Intravenous Tranexamic Acid After Simultaneous Bilateral TKA. Clin Orthop Relat Res. 2022 Apr 1;480(4):702-711. doi: 10.1097/CORR.0000000000002037.
- Results Bakke HK, Fuskevag OM, Nielsen EW, Dietrichs ES. Intramuscular uptake of tranexamic acid during haemorrhagic shock in a swine model. Scand J Trauma Resusc Emerg Med. 2021 Dec 18;29(1):171. doi: 10.1186/s13049-021-00983-2.
- Results Bury G, Fitzpatrick C, Heron B, Cullen W, Scully E, Kachurets K, Zacharchenko L. Ukraine Trauma Project: the feasibility of introducing advanced trauma-care skills to frontline emergency medical services responders. BMJ Open. 2023 Nov 9;13(11):e077895. doi: 10.1136/bmjopen-2023-077895.
- Results Vallentin MF, Granfeldt A, Meilandt C, Povlsen AL, Sindberg B, Holmberg MJ, Iversen BN, Maerkedahl R, Mortensen LR, Nyboe R, Vandborg MP, Tarpgaard M, Runge C, Christiansen CF, Dissing TH, Terkelsen CJ, Christensen S, Kirkegaard H, Andersen LW. Effect of Intravenous or Intraosseous Calcium vs Saline on Return of Spontaneous Circulation in Adults With Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2021 Dec 14;326(22):2268-2276. doi: 10.1001/jama.2021.20929.
- Results Armond DN, Goble HM, Hernandez KL, Ewing A, Taraballi F, Park KJ, McCulloch PC. Intraosseous vs. intravenous vancomycin administration in total shoulder arthroplasty: comparable tissue concentrations with better control. J Shoulder Elbow Surg. 2026 Jan;35(1):e22-e29. doi: 10.1016/j.jse.2025.04.027. Epub 2025 Jun 3.
- Results Park KJ, Wininger AE, Sullivan TC, Varghese B, Clyburn TA, Incavo SJ. Superior Clinical Results With Intraosseous Vancomycin in Primary Total Knee Arthroplasty. J Arthroplasty. 2025 Oct;40(10):2650-2654. doi: 10.1016/j.arth.2025.04.074. Epub 2025 May 5.
- Results Ng JS, van der Werf B, Nicholson L, Farrington W, Young SW. The AAHKS Clinical Research Award: Intraosseous Regional Diclofenac for Postoperative Pain Management in Total Knee Arthroplasty. J Arthroplasty. 2025 Sep;40(S19):S18-S27. doi: 10.1016/j.arth.2025.05.013. Epub 2025 May 9.
- Results Brozovich AA, Incavo SJ, Lambert BS, Sullivan TC, Wininger AE, Clyburn TA, Taraballi F, Park KJ. Intraosseous Morphine Decreases Postoperative Pain and Pain Medication Use in Total Knee Arthroplasty: A Double-Blind, Randomized Controlled Trial. J Arthroplasty. 2022 Jun;37(6S):S139-S146. doi: 10.1016/j.arth.2021.10.009. Epub 2022 Mar 7.
- Results DeSoucy ES, Davidson AJ, Hoareau GL, Simon MA, Tibbits EM, Ferencz SE, Grayson JK, Galante JM. Pharmacokinetics of Tranexamic Acid via Intravenous, Intraosseous, and Intramuscular Routes in a Porcine (Sus scrofa) Hemorrhagic Shock Model. J Spec Oper Med. 2019 Winter;19(4):80-84. doi: 10.55460/COGQ-2CY1.
- Results Newman ZC, Ogbeifun VO, Barbosa CE, McKinley WI, Benjamin AJ, Munar MY, Pramuka PE, McGovern KD, Nordgren RK, Schreiber MA, Rowell SE. Intravenous Versus Intraosseous Use of Tranexamic Acid in Patients With Traumatic Brain Injury. J Surg Res. 2024 Oct;302:798-804. doi: 10.1016/j.jss.2024.08.003. Epub 2024 Sep 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tranexamic Acid | Small molecule | 15 mg/kg | Intravenous |