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.
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.
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.
Parallel
Tranexamic Acid
DrugA 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
DrugNormal 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.
Total Perioperative Blood Loss
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.
Maximum Decrease in Hemoglobin
Maximum decrease in hemoglobin from the preoperative value to the lowest postoperative value, expressed in g/L.
Allogeneic Red Blood Cell Transfusion Rate
Proportion of participants who receive at least one allogeneic red blood cell transfusion from the start of surgery through hospital discharge.
Volume of Allogeneic Red Blood Cell Transfusion
Total volume of allogeneic red blood cells transfused from the start of surgery through hospital discharge.
Pain Intensity at Rest
Postoperative pain at rest will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
