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Starting soon Phase 4

Intraosseous Tranexamic Acid for Reducing Blood Loss in Total Knee Arthroplasty

NCT07853885 · tracked via the Priya Life Science China tracker
Phase
Phase 4
Started
2026-10
Last updated
2026-10-09

Condition(s) studied

Knee Osteoarthritis

Investigational drug(s) / intervention(s)

Tranexamic Acid →Normal Saline

Tranexamic Acid: A total dose of 2 g of tranexamic acid will be administered by local intraosseous injection before skin incision during primary unilateral total knee arthroplasty. Of the total dose, 1 g will be injected into the cancellous bone of the tibial plateau, and 1 g will be injected into the medial and lateral condyles of the distal femur. The intervention will be administered using a standardized intraosseous injection technique.

Normal Saline: Normal saline will be administered by the same local intraosseous injection procedure before skin incision during primary unilateral total knee arthroplasty. The volume, injection sites, timing, and administration procedure will be matched to those used in the experimental group.

Study summary

This prospective, single-center, randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of local intraosseous tranexamic acid administration for reducing perioperative blood loss in patients undergoing primary unilateral total knee arthroplasty (TKA). A total of 70 patients with primary knee osteoarthritis will be randomly assigned in a 1:1 ratio to either the tranexamic acid group or the placebo control group. Before skin incision, participants in the experimental group will receive local intraosseous tranexamic acid, while participants in the control group will receive an equal volume of normal saline using the same injection procedure. The primary outcome is total perioperative blood loss. Secondary outcomes include postoperative hemoglobin reduction, transfusion requirements, pain, knee swelling, range of motion, functional recovery, length of hospital stay, and postoperative complications. Participants will be followed for up to 3 months after surgery.

Eligibility

Sex
ALL
Min age
50 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * Age 50 to 85 years. * Diagnosis of primary knee osteoarthritis. * Scheduled to undergo primary unilateral total knee arthroplasty. * American Society of Anesthesiologists (ASA) physical status classification I to III. * Willing to participate in the study and able to provide written informed consent. Exclusion Criteria: * Known allergy or hypersensitivity to tranexamic acid. * History of thromboembolic disease, including deep vein thrombosis or pulmonary embolism. * Known hypercoagulable state or current use of anticoagulant therapy, except for protocol-permitted perioperative anticoagulation * Severe cardiac, hepatic, or renal dysfunction. * History of vascular stent implantation or peripheral vascular disease. * Active infection or previous surgery on the study knee. * Abnormal coagulation function, including an international normalized ratio (INR) greater than 1.5. * Pregnancy or breastfeeding.

Primary outcome measure(s)

  • Total Perioperative Blood Loss — From preoperative baseline through postoperative day 3
    Total perioperative blood loss will be calculated in milliliters (mL) using perioperative hematologic measurements and estimated blood volume based on preoperative and postoperative laboratory values.

Trial sites (1)

FacilityCityRegionStatus
The Second Affiliated Hospital of Kunming Medical University Kunming Yunnan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07853885 on ClinicalTrials.gov ↗ ← All trials in China