Intravenous tranexamic acid and lower limb arthroplasty-a randomised controlled feasibility study

Area of Science:

• Orthopedic Surgery
• Anesthesiology
• Hematology

Background:

• Tranexamic acid (TA) is recognized for reducing bleeding and transfusion needs in orthopedic surgery.
• Limited evidence exists on TA's impact on rare adverse events and patient-centered outcomes in lower limb arthroplasty.
• A large-scale randomized controlled trial (RCT) is needed to fully evaluate TA's efficacy and safety in this patient population.

Purpose of the Study:

• To assess the feasibility of conducting a large-scale RCT on intravenous (IV) tranexamic acid (TA) for lower limb arthroplasty.
• To evaluate the effectiveness of IV TA in reducing allogeneic blood transfusions in patients undergoing hip or knee replacement.
• To explore the impact of TA on adverse clinical and surgical events and patient-reported outcomes.

Main Methods:

• A prospective, randomized, double-blind, placebo-controlled trial involving 140 patients aged 45+ undergoing elective hip or knee arthroplasty.
• Participants received either IV TA or a placebo.
• Primary endpoints included transfusion rates and feasibility metrics; secondary endpoints covered adverse events and patient questionnaires.

Main Results:

• Allogeneic red blood cell transfusion was required in 15% of patients before hospital discharge.
• The TA group showed significantly lower transfusion rates (8.5%) compared to the placebo group (21.7%, P=0.03).
• Three of four feasibility endpoints were met, though patient recruitment was slower than anticipated. No significant differences in secondary outcomes were observed.

Conclusions:

• Intravenous tranexamic acid effectively reduced blood transfusion requirements in patients undergoing lower limb arthroplasty.
• The study methodology is feasible for a larger multicenter trial to definitively assess TA's safety and efficacy.
• Further research is warranted to confirm these findings and explore patient-centric benefits.