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Plasma Concentrations of Intraosseous Versus Intravenous Tranexamic Acid in Joint Arthroplasty

ConditionOsteoarthritis
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Tranexamic Acid

    Drug

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Intraosseous TXA GroupExperimental treatment 1 intervention
Group B: Intravenous TXA GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Plasma Concentration of Tranexamic Acid (μg/mL)

Arterial blood samples will be collected at predefined time points after tranexamic acid administration to evaluate plasma concentrations following intraosseous and intravenous administration.

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

Secondary outcomes

1

D-dimer (mg/L)

Assessment of perioperative coagulation parameters following intraosseous or intravenous tranexamic acid administration during joint arthroplasty.

Time frame
Preoperatively and within 18 hours postoperatively
2

Fibrinogen(g/L)

Assessment of perioperative coagulation parameters following intraosseous or intravenous tranexamic acid administration during joint arthroplasty.

Time frame
Preoperatively and within 18 hours postoperatively
3

Hemoglobin

Assessment of perioperative hemoglobin changes following intraosseous or intravenous tranexamic acid administration during joint arthroplasty.

Time frame
Baseline and 18 hours after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hua Luo

Lead sponsor

Taizhou Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: