Shaoyun Zhang1, Cong Xiao1, Wei Yu1, Nengji Long1, Fenglai He1, Peng Cai1, Kairong Luo1, Yishan Jiang2. 1. Department of Orthopedics, The Third Hospital of Mianyang, Sichuan Mental Health Center, No. 190 The East Jiannan Road, Mianyang, 621000, China. 2. Department of Orthopedics, The Third Hospital of Mianyang, Sichuan Mental Health Center, No. 190 The East Jiannan Road, Mianyang, 621000, China. jiangysh@126.com.
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.
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.