Plasma Concentrations of Intraosseous Versus Intravenous Tranexamic Acid in Joint Arthroplasty

Condition(s) studied

Investigational drug(s) / intervention(s)

Tranexamic Acid: 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.

Study 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

Primary outcome measure(s)

• Plasma Concentration of Tranexamic Acid (μg/mL) — 1 minute, 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 6 hours, and 18 hours after tranexamic acid administration
  Arterial blood samples will be collected at predefined time points after tranexamic acid administration to evaluate plasma concentrations following intraosseous and intravenous administration.

Trial sites (1)

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