Plasma Concentrations of Intraosseous Versus Intravenous Tranexamic Acid in Joint Arthroplasty

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHua Luo

About this trial

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

Qualifiers

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

Disqualifiers

History of coagulation disorders or bleeding disorders

History of pulmonary embolism

Known allergy to tranexamic acid

Pregnancy or breastfeeding

Trial design

Treatments tested in this trial

  • Tranexamic Acid

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Hua Luo

Lead sponsor

Taizhou Hospital

Sponsor institution