Effectiveness and safety of Tranexamic acid in the prevention of hemorrhages and blood transfusion in patients exposed to major orthopedic surgery

The tranexamic acid (TXA) has been increasingly used in major orthopedic surgeries, since it significantly reduces blood loss and transfusion requirements. This study assessed the effectiveness and safety of TXA in prevention of hemorrhage and blood transfusion in adults exposed to major orthopedic surgery. A non-randomized clinical study was conducted in 50 adults who received topic and intravenous TXA in the total knee or hip arthroplasty. These patients were compared and matched with a historical control group of 94 adults. Preoperative TXA administration was of 1 gram infused intravenously over 10 minutes, and 30 minutes before surgery. Topical and trans-operative use of TXA in the total knee arthroplasty was using 1.5 grams diluted in 15 ml of saline or Ringer’s solution and topically applied by a pulsatile lavage over the distal femur, proximal tibia, and its medullary canal; while topical use in the total hip arthroplasty was by pulsatile lavage with the same dose and dilution inside the femoral medullary canal and the acetabular space. To assess the risk of excessive bleeding, hemoglobin reduction and risk of transfusion comparing the TXA group versus control group, bivariate and multivariate logistic regression models were performed. A p value ≤ 0.05 was considered a statistically significant difference. Participants who received TXA showed 58% lower likelihood of bleeding greater than 500 ml (p=0.025), 67% lower risk of reducing hemoglobin by -2.5 grams or more (p=0.013), and a reduced their risk of transfusion by 68% (p=0.043), compared to those who did not receive TXA. In major orthopedic surgeries TXA significantly reduced the probability of bleeding, transfusions and lowered hemoglobin after surgery. This study provides scientific evidences about the effectiveness and pharmacovigilance for TXA.