MedTrace Logo

Plasma Concentrations of Intraosseous Versus Intravenous Tranexamic Acid in Joint Arthroplasty

NCT07614087 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-05-29

No results posted yet for this 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.

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.

Sponsors & Collaborators

  • Hua Luo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-27
Primary Completion
2026-06-03
Completion
2026-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07614087 on ClinicalTrials.gov