Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, China.
Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, China.
BMC Musculoskelet Disord. 2020 Jul 15;21(1):465. doi: 10.1186/s12891-020-03488-8.
Patients with rheumatoid arthritis (RA) who have undergone total knee arthroplasty are at increased risk of requiring a blood transfusion. This study is designed to compare the effects of preemptive antifibrinolysis of single-dose and repeat-dose tranexamic acid (TXA) in in RA patients undergoing total knee arthroplasty (TKA).
METHODS/DESIGN: The study will be a double-blind randomized controlled trial with two parallel groups of RA patients. Group A will be given 100 ml normal saline twice daily starting from 3 days before the operation, Group B will be given TXA 1.5 g twice daily starting from 3 days before the operation. All patients will be given TXA 1.5 g 30 min before the operation. The primary outcomes will be evaluated with total blood loss and hidden blood loss. Other outcome measurements such as, fibrinolysis parameters, inflammatory factors, visual analogue scale for post-operative pain, analgesia usage, coagulation parameters, transfusion, the length of stay (LOS), total hospitalization costs, the incidence of thromboembolic events and other complications will be recorded and compared. Recruitment is scheduled to begin on 1 August 2020, and the study will continue until 31 May 2021.
In current literature there is a lack of evidence with regard to the efficacy of TXA in RA patients. The findings of this study, whether positive or negative, will contribute to the formulation of further recommendations on the use of TXA in RA patients undergoing TKA.
Chinese Clinical Trial Registry, ChiCTR2000029720 . Registered 14 February 2020.
接受全膝关节置换术的类风湿关节炎（RA）患者有更高的输血风险。本研究旨在比较单次和重复剂量氨甲环酸（TXA）在接受全膝关节置换术（TKA）的 RA 患者中的预先抗凝作用。
方法/设计：该研究将是一项双盲随机对照试验，有两个平行的 RA 患者组。A 组从手术前 3 天开始每天两次给予 100ml 生理盐水，B 组从手术前 3 天开始每天两次给予 TXA 1.5g。所有患者将在手术前 30 分钟给予 TXA 1.5g。主要结局将通过总失血量和隐性失血量进行评估。其他结局测量指标，如纤溶参数、炎症因子、术后疼痛视觉模拟评分、镇痛药物使用、凝血参数、输血、住院时间（LOS）、总住院费用、血栓栓塞事件和其他并发症的发生率等，也将进行记录和比较。招募计划于 2020 年 8 月 1 日开始，研究将持续到 2021 年 5 月 31 日。
目前的文献中缺乏 TXA 在 RA 患者中有效性的证据。本研究的结果，无论是否阳性，都将有助于制定关于 TXA 在接受 TKA 的 RA 患者中的使用的进一步建议。
中国临床试验注册中心，ChiCTR2000029720。注册于 2020 年 2 月 14 日。
