Department of Orthopedic Surgery, Anderson Orthopaedic Research Institute, Alexandria, Virginia.
Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois.
J Bone Joint Surg Am. 2020 Nov 4;102(21):1883-1890. doi: 10.2106/JBJS.20.00010.
The purpose of this multicenter, randomized trial was to determine the optimal dosing regimen of tranexamic acid (TXA) to minimize perioperative blood loss in revision total hip arthroplasty.
Six centers prospectively randomized 175 patients to 1 of 4 regimens: (1) 1-g intravenous (IV) TXA prior to incision (the single-dose IV group), (2) 1-g IV TXA prior to incision followed by 1-g IV TXA after arthrotomy wound closure (the double-dose IV group), (3) a combination of 1-g IV TXA prior to incision and 1-g intraoperative topical TXA (the combined IV and topical group), or (4) 3 doses totaling 1,950-mg oral TXA (the multidose oral group). Randomization was based on revision subgroups to ensure equivalent group distribution. An a priori power analysis (α = 0.05; β = 0.80) determined that 40 patients per group were required to identify a >1-g/dL difference in postoperative hemoglobin reduction between groups. Per-protocol analysis involved an analysis of variance, Fisher exact tests, and two 1-sided t tests for equivalence. Demographic and surgical variables were equivalent between groups.
No significant differences were found between TXA regimens when evaluating reduction in hemoglobin (3.4 g/dL for the single-dose IV group, 3.6 g/dL for the double-dose IV group, 3.5 g/dL for the combined IV and topical group, and 3.4 g/dL for the multidose oral group; p = 0.95), calculated blood loss (p = 0.90), or transfusion rates (14% for the single-dose IV group, 18% for the double-dose IV group, 17% for the combined group, and 17% for the multidose oral group; p = 0.96). Equivalence testing revealed that all possible pairings were statistically equivalent, assuming a >1-g/dL difference in hemoglobin reduction as clinically relevant. There was 1 venous thromboembolism, with no differences found between groups (p = 1.00).
All 4 TXA groups tested had equivalent blood-sparing properties in the setting of revision total hip arthroplasty, with a single venous thromboembolism reported in this high-risk population. Based on the equivalence between groups, surgeons should utilize whichever of the 4 investigated regimens is best suited for their practice and hospital setting. Given the transfusion rate in revision total hip arthroplasty despite TXA utilization, further work is required in this area.
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
本多中心、随机试验的目的是确定氨甲环酸（TXA）的最佳剂量方案，以最大限度地减少翻修全髋关节置换术的围手术期失血。
6 个中心前瞻性地将 175 名患者随机分为 4 组中的 1 组：（1）切口前静脉（IV）给予 1gTXA（单次 IV 组），（2）切口前给予 1gTXA，然后在关节切开伤口闭合后给予 1gIVTXA（双剂量 IV 组），（3）切口前给予 1gIVTXA 与术中给予 1g 局部 TXA 的联合用药（联合 IV 和局部 TXA 组），或（4）口服 3 剂共 1950mgTXA（多剂量口服组）。基于翻修亚组进行随机分组，以确保各组分布均衡。预先进行的功效分析（α=0.05；β=0.80）确定每组需要 40 例患者，以确定组间术后血红蛋白降低超过 1g/dL 的差异。方案分析包括方差分析、Fisher 精确检验和两种等效性单侧 t 检验。各组之间的人口统计学和手术变量没有差异。
当评估血红蛋白减少时，TXA 方案之间没有发现显著差异（单次 IV 组为 3.4g/dL，双剂量 IV 组为 3.6g/dL，联合 IV 和局部 TXA 组为 3.5g/dL，多剂量口服组为 3.4g/dL；p=0.95），计算失血量（p=0.90）或输血率（单次 IV 组为 14%，双剂量 IV 组为 18%，联合组为 17%，多剂量口服组为 17%；p=0.96）。等效性检验表明，假设血红蛋白减少超过 1g/dL 具有临床意义，所有可能的配对在统计学上都是等效的。在该高危人群中，报告了 1 例静脉血栓栓塞事件，但各组之间无差异（p=1.00）。
在翻修全髋关节置换术中，所有 4 种测试的 TXA 方案均具有等效的血液节约特性，在该高危人群中报告了 1 例静脉血栓栓塞事件。基于组间等效性，外科医生应根据自身的实践和医院环境选择最合适的 4 种方案之一。尽管使用了 TXA，但在翻修全髋关节置换术中仍存在输血率，因此在该领域需要进一步研究。
治疗性 1 级。有关证据水平的完整描述，请参见作者说明。
