Plasma Concentrations of Intraosseous Versus Intravenous Tranexamic Acid in Joint Arthroplasty

Sponsor
Hua Luo
Study ID
NCT07614087
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
May 29, 2026
Start date
May 27, 2026
Status verified
May 2026
Primary completion
Jun 3, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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
  • Active Comparator: Intravenous TXA Group
    Participants receive intravenous tranexamic acid administration at a dose of 15 mg/kg during joint arthroplasty.

Primary Outcome Measure

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 ]

Central Contacts

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