Zhuang Zhang1, Lin-Nan Wang1, Xi Yang1, Li-Min Liu1, Peng Xiu1, Zhong-Jie Zhou1, Lei Wang1, Yue-Ming Song2. 1. Department of Orthopedic Surgery and Orthopedic Research Institute, West China Hospital, Sichuan University, No.37, Guoxue Rd, Wuhou District, Chengdu 610041, Sichuan, People's Republic of China. 2. Department of Orthopedic Surgery and Orthopedic Research Institute, West China Hospital, Sichuan University, No.37, Guoxue Rd, Wuhou District, Chengdu 610041, Sichuan, People's Republic of China. Electronic address: prof_songyueming@163.com.
Abstract
BACKGROUND CONTEXT: Tranexamic acid (TXA) is widely used in surgery for adolescent idiopathic scoliosis (AIS) and has been proved to be efficacious in reducing intraoperative blood loss (IBL) and the transfusion rate. However, the routine TXA regimen was intraoperative administration alone, in which the concentration of TXA could not cover the whole process of hyperfibrinolysis. And, its ability to control the massive postoperative blood loss (PBL) may be insufficient. Thus, we promoted a multiple-dose regimen of TXA for patients with AIS who underwent surgical correction. PURPOSE: The primary aims were (1) to determine whether the multiple-dose regimen of TXA could reduce PBL and the postoperative transfusion rate, and (2) to compare the efficacy of oral administration with intravenous administration. The secondary aims were (3) to evaluate whether this regimen could alleviate inflammatory response, and (4) to assess the occurrence of drug-related side effects. STUDY DESIGN: Prospective, double-blinded, randomized controlled trial. PATIENT SAMPLE: A total of 108 patients with AIS who underwent posterior scoliosis correction and spinal fusion (PSS) were enrolled in this study. OUTCOME MEASURES: The primary parameters were PBL and postoperative transfusion rate. Other parameters such as total blood loss (TBL), maximum hemoglobin (Hb) decrease, volume of drainage, inflammation markers (interleukin-6 [IL-6] and C-reactive protein [CRP]), and occurrence of complications were also collected and compared. Multiple regression analysis was used to examine the variables that affected PBL. METHODS: Patients were randomized into three groups. All patients received intravenous TXA 50 mg/kg loading dose and 10 mg/kg/h maintenance dose during surgery. Group A received 1 g oral TXA at 4 hours, 10 hours, and 16 hours postoperatively; group B received 0.5 g intravenous TXA at 6 hours, 12 hours, and 18 hours postoperatively; group C received placebo. RESULTS: The mean PBL and postoperative transfusion rate in group A (957.8±378.9 mL, 13.89%) and B (980.3±491.8 mL, 11.11%) were significantly lower than those in group C [1,495.9±449.6 mL, mean differences=538.1 mL, 95% confidence interval (CI), 290.1-786.1 mL, p<0.001; 515.6 mL, 95% CI, 267.6-763.6 mL, p<.001]; (36.11%, p=.029, p=.013). Meanwhile, the mean TBL, maximum Hb decrease, and volume of drainage were also significantly lower in group A and B than in group C. IL-6 and CRP in group A and B were significantly lower than in group C from postoperative days 1 to 3. All these differences were not significant between groups A and B. No drug-related complications were observed in any patient. Multiple regression showed that the application of postoperative TXA and number of screws were significant parameters affecting PBL. CONCLUSIONS: A multiple-dose regimen of TXA, either by oral or intravenous application, could be a safe and effective means of controlling PBL and decreasing the postoperative transfusion rate in patients with AIS who underwent scoliosis surgery. In addition, it could inhibit postoperative inflammatory response.
RCT Entities:
BACKGROUND CONTEXT: Tranexamic acid (TXA) is widely used in surgery for adolescent idiopathic scoliosis (AIS) and has been proved to be efficacious in reducing intraoperative blood loss (IBL) and the transfusion rate. However, the routine TXA regimen was intraoperative administration alone, in which the concentration of TXA could not cover the whole process of hyperfibrinolysis. And, its ability to control the massive postoperative blood loss (PBL) may be insufficient. Thus, we promoted a multiple-dose regimen of TXA for patients with AIS who underwent surgical correction. PURPOSE: The primary aims were (1) to determine whether the multiple-dose regimen of TXA could reduce PBL and the postoperative transfusion rate, and (2) to compare the efficacy of oral administration with intravenous administration. The secondary aims were (3) to evaluate whether this regimen could alleviate inflammatory response, and (4) to assess the occurrence of drug-related side effects. STUDY DESIGN: Prospective, double-blinded, randomized controlled trial. PATIENT SAMPLE: A total of 108 patients with AIS who underwent posterior scoliosis correction and spinal fusion (PSS) were enrolled in this study. OUTCOME MEASURES: The primary parameters were PBL and postoperative transfusion rate. Other parameters such as total blood loss (TBL), maximum hemoglobin (Hb) decrease, volume of drainage, inflammation markers (interleukin-6 [IL-6] and C-reactive protein [CRP]), and occurrence of complications were also collected and compared. Multiple regression analysis was used to examine the variables that affected PBL. METHODS:Patients were randomized into three groups. All patients received intravenous TXA 50 mg/kg loading dose and 10 mg/kg/h maintenance dose during surgery. Group A received 1 g oral TXA at 4 hours, 10 hours, and 16 hours postoperatively; group B received 0.5 g intravenous TXA at 6 hours, 12 hours, and 18 hours postoperatively; group C received placebo. RESULTS: The mean PBL and postoperative transfusion rate in group A (957.8±378.9 mL, 13.89%) and B (980.3±491.8 mL, 11.11%) were significantly lower than those in group C [1,495.9±449.6 mL, mean differences=538.1 mL, 95% confidence interval (CI), 290.1-786.1 mL, p<0.001; 515.6 mL, 95% CI, 267.6-763.6 mL, p<.001]; (36.11%, p=.029, p=.013). Meanwhile, the mean TBL, maximum Hb decrease, and volume of drainage were also significantly lower in group A and B than in group C. IL-6 and CRP in group A and B were significantly lower than in group C from postoperative days 1 to 3. All these differences were not significant between groups A and B. No drug-related complications were observed in any patient. Multiple regression showed that the application of postoperative TXA and number of screws were significant parameters affecting PBL. CONCLUSIONS: A multiple-dose regimen of TXA, either by oral or intravenous application, could be a safe and effective means of controlling PBL and decreasing the postoperative transfusion rate in patients with AIS who underwent scoliosis surgery. In addition, it could inhibit postoperative inflammatory response.
Authors: Breanne H Y Gibson; Matthew T Duvernay; Lydia J McKeithan; Teresa A Benvenuti; Tracy A Warhoover; Jeffrey E Martus; Gregory A Mencio; Brian R Emerson; Stephanie N Moore-Lotridge; Alexandra J Borst; Jonathan G Schoenecker Journal: Spine Deform Date: 2022-03-05
Authors: Lily Eaker; Stephen R Selverian; Laura N Hodo; Jonathan Gal; Sandeep Gangadharan; James Meyers; Sergei Dolgopolov; Baron Lonner Journal: Spine Deform Date: 2022-03-09