Tranexamic acid safely reduces hidden blood loss in patients undergoing intertrochanteric fracture surgery: a randomized controlled trial.

Abstract

To investigate the efficacy and safety of intravenous tranexamic acid (IV-TXA) in patients undergoing intertrochanteric fracture surgery. A total of 122 patients were included in this double-blinded trial and equally randomized to receive 1g of IV-TXA or normal saline 10min before incision and 3h later. The primary efficacy outcome was calculated hidden blood loss (HBL). The secondary efficacy outcome was allogeneic erythrocyte transfusion rate during hospitalization. Safety outcome was a composite of thromboembolic events including deep venous thrombosis (DVT) up to 90days. A meta-analysis combining this study with previous randomized controlled trials in hip fracture surgery (total sample size: 1112 patients) was also conducted. The mean HBL in TXA group (640.96 ± 421.63ml) was significantly lower than that in placebo group (1010.11 ± 398.96ml, P < 0.001). The rate of erythrocyte transfusions was 29.5% in TXA group and 60.7% in placebo group (P = 0.001). The incidence of thromboembolic events at 90days was 4.9% in TXA group and 1.6% in placebo group (P = 0.619). The updated meta-analysis showed that IV-TXA significantly reduced erythrocyte transfusion in hip fracture surgery (risk ratio 0.60, 95% confidence intervals 0.53-0.68), and IV-TXA caused no increased risk of thromboembolic events (risk difference 0.01, 95% confidence intervals - 0.02-0.04). IV-TXA could effectively reduce the HBL and allogeneic erythrocyte transfusion requirements in patients undergoing intertrochanteric fracture surgery without an increase of thromboembolic events including DVT. Clinical trials: safety and efficiency of tranexamic acid in hip fracture patients. Date of registration: August 31, 2018. ChiCTR1800018110.