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NOT YET RECRUITING
NCT07614087
PHASE4

Plasma Concentrations of Intraosseous Versus Intravenous Tranexamic Acid in Joint Arthroplasty

Sponsor: Hua Luo

View on ClinicalTrials.gov

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.

Official title: A Prospective Randomized Controlled Trial Comparing Plasma Concentrations of Intraosseous and Intravenous Tranexamic Acid in Patients Undergoing Joint Arthroplasty

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-05-27

Completion Date

2026-12-30

Last Updated

2026-06-11

Healthy Volunteers

No

Conditions

Interventions

DRUG

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.

Locations (1)

No. 150 Ximen Road

Linhai, Zhejiang, China