Plasma Concentrations of Intraosseous Versus Intravenous Tranexamic Acid in Joint Arthroplasty (IO TXA)

May 28, 2026 updated by: Hua Luo

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective randomized controlled trial designed to compare the plasma concentration profiles and pharmacokinetic characteristics of intraosseous and intravenous tranexamic acid administration in patients undergoing primary total joint arthroplasty.

A total of 80 patients scheduled for primary total hip arthroplasty or total knee arthroplasty will be enrolled. Sample size calculation was based on an equivalence design with a significance level of 0.05 and a statistical power of 80%. Considering a dropout rate of approximately 10%, 40 patients will be included in each group. Patients will be stratified according to surgical procedure type and randomly assigned in a 1:1 ratio to either the intraosseous group or the intravenous group using a computer generated randomization sequence.

Eligible participants include patients aged 18 to 80 years with osteoarthritis undergoing primary total hip or total knee arthroplasty and classified as ASA physical status I-III. Key exclusion criteria include coagulation disorders, prior pulmonary embolism, tranexamic acid allergy, severe hepatic or renal dysfunction, anticoagulant use, pregnancy, and body mass index greater than 40 kg/m².

Both groups will receive tranexamic acid at a standardized dose of 15 mg/kg. In the intraosseous group, patients undergoing total knee arthroplasty will receive intraosseous injection into the proximal tibial cancellous bone before tourniquet release, while patients undergoing total hip arthroplasty will receive intraosseous injection into the proximal femoral cancellous bone before skin incision. In the intravenous group, tranexamic acid will be administered intravenously.

Arterial blood samples will be collected at 1 minute, 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 6 hours, and 18 hours after administration for plasma concentration analysis and pharmacokinetic curve construction. Secondary outcomes include coagulation parameters, intraoperative blood loss, transfusion rate, and hemoglobin changes. The study aims to clarify the perioperative pharmacokinetic characteristics and potential clinical value of intraosseous tranexamic acid administration in joint arthroplasty.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Linhai, Zhejiang, China, 317000
        • No. 150 Ximen Road

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intraosseous TXA Group

Knee: Before tourniquet release, a dedicated intraosseous needle was inserted into the proximal tibial cancellous bone adjacent to the tibial tubercle, and tranexamic acid (15 mg/kg) was administered intraosseously.

Hip: Before skin incision, a dedicated intraosseous needle was inserted into the proximal femoral cancellous bone adjacent to the greater trochanter, and tranexamic acid (15 mg/kg) was administered intraosseously
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.
Other Names:
  • TXA
Active Comparator: Intravenous TXA Group
Participants receive intravenous tranexamic acid administration at a dose of 15 mg/kg during joint arthroplasty.
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.
Other Names:
  • TXA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Concentration of Tranexamic Acid (μg/mL)
Time Frame: 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.
1 minute, 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 6 hours, and 18 hours after tranexamic acid administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
D-dimer (mg/L)
Time Frame: Preoperatively and within 18 hours postoperatively
Assessment of perioperative coagulation parameters following intraosseous or intravenous tranexamic acid administration during joint arthroplasty.
Preoperatively and within 18 hours postoperatively
Fibrinogen(g/L)
Time Frame: Preoperatively and within 18 hours postoperatively
Assessment of perioperative coagulation parameters following intraosseous or intravenous tranexamic acid administration during joint arthroplasty.
Preoperatively and within 18 hours postoperatively
Hemoglobin
Time Frame: Baseline and 18 hours after surgery
Assessment of perioperative hemoglobin changes following intraosseous or intravenous tranexamic acid administration during joint arthroplasty.
Baseline and 18 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hua Luo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 27, 2026

Primary Completion (Estimated)

June 3, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

May 22, 2026

First Submitted That Met QC Criteria

May 28, 2026

First Posted (Actual)

May 29, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K20251218

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared because no public data sharing plan has been established for this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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