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

Abstract

Purpose To investigate the efficacy and safety of intravenous tranexamic acid (IV-TXA) in patients undergoing intertrochanteric fracture surgery. Methods A total of 122 patients were included in this double-blinded trial and equally randomized to receive 1 g of IV-TXA or normal saline 10 min before incision and 3 h 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 90 days. A meta-analysis combining this study with previous randomized controlled trials in hip fracture surgery (total sample size: 1112 patients) was also conducted. Results The mean HBL in TXA group (640.96 ± 421.63 ml) was significantly lower than that in placebo group (1010.11 ± 398.96 ml, 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 90 days 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). Conclusion 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. Trial registration Clinical trials: safety and efficiency of tranexamic acid in hip fracture patients. Date of registration: August 31, 2018. Trial registration number: ChiCTR1800018110.