Department of Orthopedics, The Third Hospital of Mianyang, Sichuan Mental Health Center, No. 190 The East Jiannan Road, Mianyang, 621000, China.
Eur J Trauma Emerg Surg. 2022 Apr;48(2):731-741. doi: 10.1007/s00068-020-01387-0. Epub 2020 May 15.
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 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.
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).
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.
研究静脉注射氨甲环酸（IV-TXA）在股骨转子间骨折手术患者中的疗效和安全性。
本双盲试验共纳入 122 名患者，随机均分为两组，分别于切皮前 10 分钟和 3 小时后接受 1 g IV-TXA 或生理盐水治疗。主要疗效结局为隐性失血量（HBL）。次要疗效结局为住院期间异体红细胞输注率。安全性结局为包括深静脉血栓形成（DVT）在内的血栓栓塞事件的综合发生率，达 90 天。还对该研究与先前髋关节骨折手术的随机对照试验（总样本量：1112 名患者）进行了荟萃分析。
TXA 组的平均 HBL（640.96±421.63ml）明显低于安慰剂组（1010.11±398.96ml，P<0.001）。TXA 组的红细胞输注率为 29.5%，安慰剂组为 60.7%（P=0.001）。TXA 组 90 天血栓栓塞事件发生率为 4.9%，安慰剂组为 1.6%（P=0.619）。更新的荟萃分析显示，IV-TXA 可显著减少髋关节骨折手术中的红细胞输注（风险比 0.60，95%置信区间 0.53-0.68），且不会增加血栓栓塞事件的风险（差异 0.01，95%置信区间-0.02-0.04）。
IV-TXA 可有效降低股骨转子间骨折手术患者的 HBL 和异体红细胞输注需求，且不会增加包括 DVT 在内的血栓栓塞事件。
氨甲环酸在髋部骨折患者中的安全性和有效性。注册日期：2018 年 8 月 31 日。
ChiCTR1800018110。
