Plasma Concentrations of Intraosseous Versus Intravenous Tranexamic Acid in Joint Arthroplasty

NCT07614087 | Not Yet Recruiting Phase 4

• 1 other identifier: K20251218
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Plasma Concentration of Tranexamic Acid (μg/mL)

  Arterial blood samples will be collected at predefined time points after tranexamic acid administration to evaluate plasma concentrations following intraosseous and intravenous administration.

  1 minute, 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 6 hours, and 18 hours after tranexamic acid administration

Secondary Outcomes (3)

• D-dimer (mg/L)

  Preoperatively and within 18 hours postoperatively

• Fibrinogen(g/L)

  Preoperatively and within 18 hours postoperatively

• Hemoglobin

  Baseline and 18 hours after surgery

Study Arms (2)

Intraosseous TXA Group

EXPERIMENTAL

Knee: Before tourniquet release, a dedicated intraosseous needle was inserted into the proximal tibial cancellous bone adjacent to the tibial tubercle, and tranexamic acid (15 mg/kg) was administered intraosseously. Hip: Before skin incision, a dedicated intraosseous needle was inserted into the proximal femoral cancellous bone adjacent to the greater trochanter, and tranexamic acid (15 mg/kg) was administered intraosseously

Drug: Tranexamic Acid

Intravenous TXA Group

ACTIVE COMPARATOR

Participants receive intravenous tranexamic acid administration at a dose of 15 mg/kg during joint arthroplasty.

Drug: Tranexamic Acid

Interventions

Tranexamic Acid DRUG

Tranexamic acid was administered at a dose of 15 mg/kg during joint arthroplasty. Depending on study group assignment, the drug was administered either through peripheral intravenous injection or intraosseous injection into the proximal tibial or proximal femoral cancellous bone using a dedicated intraosseous needle.

Also known as: TXA

Intraosseous TXA Group; Intravenous TXA Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 80 years
• Patients scheduled for primary total hip arthroplasty or total knee arthroplasty
• Diagnosis of osteoarthritis
• American Society of Anesthesiologists (ASA) physical status I-III
• Preoperative hemoglobin ≥ 9 g/dL
• Ability to provide written informed consent
• Willingness to comply with postoperative follow up and study procedures

You may not qualify if:

• History of coagulation disorders or bleeding disorders
• History of pulmonary embolism
• Known allergy to tranexamic acid
• Pregnancy or breastfeeding
• Severe hepatic or renal dysfunction
• Preoperative anticoagulant therapy
• Body mass index \> 40 kg/m²
• Body weight \< 45 kg

Sponsors & Collaborators

• Hua Luo: lead

Study Sites (1)

No. 150 Ximen Road

Linhai, Zhejiang, 317000, China

Location

Related Publications (15)

• 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.

  PMID: 40591647 RESULT

• 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.

  PMID: 40735345 RESULT

• 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.

  PMID: 36526484 RESULT

• 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.

  PMID: 40611356 RESULT

• 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.

  PMID: 39064612 RESULT

• 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.

  PMID: 35302971 RESULT

• 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.

  PMID: 34922577 RESULT

• 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.

  PMID: 37945303 RESULT

• 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.

  PMID: 34847226 RESULT

• 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.

  PMID: 40472958 RESULT

• 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.

  PMID: 40334953 RESULT

• 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(9S1):S18-S27. doi: 10.1016/j.arth.2025.05.013. Epub 2025 May 9.

  PMID: 40349862 RESULT

• 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.

  PMID: 35272897 RESULT

• 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.

  PMID: 31910476 RESULT

• 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.

  PMID: 39226704 RESULT

MeSH Terms

Conditions

Osteoarthritis

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Hua Luo, Dr.

CONTACT

0576-85190460; luohua66ry@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: May 27, 2026
• Primary Completion: June 3, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)