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NCT07614087
Plasma Concentrations of Intraosseous Versus Intravenous Tranexamic Acid in Joint Arthroplasty
Conditions: Osteoarthritis
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 80
Sponsor: Hua Luo
Location: No. 150 Ximen Road Linhai Zhejiang
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.
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT07614087). StuddyBuddy aggregates publicly available trial information.