Lu Zhang1,2, Yanming Li3, Dong Liu4, Xing Xiao5, Tingjin Guan6, Hongwei Yue7, Haipeng Xue8, Hongming Zhou9, Guangjun Jiao1,2, Wenliang Wu1,2, Hongliang Wang1,2, Haichun Liu1,2, Chunyang Meng3, Zhaozhong Sun4, Yunzhen Chen10,11. 1. Department of Spine Surgery, Qilu Hospital, Shandong University, 107, West Culture Road, Lixia District, Jinan, China. 2. Department of Shandong University Spine and Spine Cord Disease Research Center, Jinan, Shandong, China. 3. Department of Spine Surgery, Affiliated Hospital of Jining Medical University, 89 Guhuai Road, Jining, China. 4. Department of Spine Surgery, Binzhou Medical University Hospital, 661 Huanghe 2nd Road, Binzhou, China. 5. Department of Spine Surgery, Shandong Provincial Qianfoshan Hospital, 16766 Jingshi Road, Jinan, China. 6. Department of Spine Surgery, The First Hospital of Zibo City, 4, East Emeishan Road, Boshan District, Zibo, China. 7. Department of Spine Surgery, Dezhou People's Hospital, 1166, Dongfanghong West Road, Decheng District, Dezhou, China. 8. Department of Spine Surgery, Shandong Provincial Hospital of Traditional Chinese Medicine, 16369 Jingshi Road, Jinan, China. 9. Department of Spine Surgery, Linyi Central Hospital, 17, Jiankang Road, Yishui County, Linyi, China. 10. Department of Spine Surgery, Qilu Hospital, Shandong University, 107, West Culture Road, Lixia District, Jinan, China. qilucyz@yeah.net. 11. Department of Shandong University Spine and Spine Cord Disease Research Center, Jinan, Shandong, China. qilucyz@yeah.net.
Abstract
PURPOSE: This prospective, stratified, randomized, single-blind, placebo-controlled multicentre study investigated the safety and effectiveness of reducing blood loss and preventing venous thromboembolism (VTE) during posterior lumbar interbody fusion (PLIF) in patients with stenosis or spondylolisthesis using the combination oftranexamic acid (TXA) and rivaroxaban. METHODS: The Autar score was evaluated in patients after admission. Patients with an Autar score ≤ 10 were randomized to group A or B. Group A was the placebo-controlled group. Patients in group B were treated with 1 g TXA via intravenous injection and 1 g TXA for external use. Patients with an Autar score > 10 were randomized to group C or D. Patients in group C were treated with 10-mg rivaroxaban qd for 35 days after surgery. Patients in group D received the same treatment as those in group B intra-operatively and as those in group C post-operatively. RESULTS: A total of 599 patients from eight hospitals participated in this clinical trial. The total blood loss, intra-operative blood loss, and drainage volume were reduced by the administration of TXA (group A vs group B, P < 0.01; group C vs group D, P < 0.01), and the blood transfusion rate was also decreased (group A vs group B, P < 0.01; group C vs group D, P < 0.01). There were no significant differences (P > 0.05) in the VTE incidence rates among group A and group B. In patients with high-risk thrombosis, the number of patients with VTE was only three and seven after the application of rivaroxaban. Epidural haematoma was not discovered in any patients in our trial. CONCLUSION: The combined application of tranexamic acid and rivaroxaban significantly reduced the amount of blood loss and the transfusion rate during PLIF surgery and avoided an increase in the probability of thrombosis and the occurrence of epidural haematoma. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION: ChiCTR-1800016430 2018-06-01.
RCT Entities:
PURPOSE: This prospective, stratified, randomized, single-blind, placebo-controlled multicentre study investigated the safety and effectiveness of reducing blood loss and preventing venous thromboembolism (VTE) during posterior lumbar interbody fusion (PLIF) in patients with stenosis or spondylolisthesis using the combination of tranexamic acid (TXA) and rivaroxaban. METHODS: The Autar score was evaluated in patients after admission. Patients with an Autar score ≤ 10 were randomized to group A or B. Group A was the placebo-controlled group. Patients in group B were treated with 1 g TXA via intravenous injection and 1 g TXA for external use. Patients with an Autar score > 10 were randomized to group C or D. Patients in group C were treated with 10-mg rivaroxaban qd for 35 days after surgery. Patients in group D received the same treatment as those in group B intra-operatively and as those in group C post-operatively. RESULTS: A total of 599 patients from eight hospitals participated in this clinical trial. The total blood loss, intra-operative blood loss, and drainage volume were reduced by the administration of TXA (group A vs group B, P < 0.01; group C vs group D, P < 0.01), and the blood transfusion rate was also decreased (group A vs group B, P < 0.01; group C vs group D, P < 0.01). There were no significant differences (P > 0.05) in the VTE incidence rates among group A and group B. In patients with high-risk thrombosis, the number of patients with VTE was only three and seven after the application of rivaroxaban. Epidural haematoma was not discovered in any patients in our trial. CONCLUSION: The combined application of tranexamic acid and rivaroxaban significantly reduced the amount of blood loss and the transfusion rate during PLIF surgery and avoided an increase in the probability of thrombosis and the occurrence of epidural haematoma. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION: ChiCTR-1800016430 2018-06-01.