Anaesthesia Department, Hospital Universitari Vall d'Hebron, Barcelona, Universitat Autònoma Barcelona, Spain.
Anaesthesia Department, Hospital Universitari Bellvitge, Barcelona, Spain.
Br J Anaesth. 2017 Mar 1;118(3):380-390. doi: 10.1093/bja/aew434.
Perioperative tranexamic acid (TXA) use can reduce bleeding and transfusion requirements in several types of surgery, but level I evidence proving its effectiveness in major spine surgery is lacking. This study was designed to investigate the hypothesis that TXA reduces perioperative blood loss and transfusion requirements in patients undergoing major spine procedures.
We conducted a multicentre, prospective, randomized double-blind clinical trial, comparing TXA with placebo in posterior instrumented spine surgery. Efficacy was determined based on the total number of blood units transfused and the perioperative blood loss. Other variables such as the characteristics of surgery, length of hospital stay, and complications were also analysed.
Ninety-five patients undergoing posterior instrumented spine surgery (fusion of >3 segments) were enrolled and randomized: 44 received TXA (TXA group) and 51 received placebo (controls). The groups were comparable for duration of surgery, number of levels fused, and length of hospitalization. Transfusion was not required in 48% of subjects receiving TXA compared with 33% of controls (P = 0.05). Mean number of blood units transfused was 0.85 in the TXA group and 1.42 with placebo (P = 0.06). TXA resulted in a significant decrease in intraoperative bleeding (P = 0.01) and total bleeding (P = 0.01) relative to placebo. The incidence of adverse events was similar in the two groups.
TXA did not significantly reduce transfusion requirements, but significantly reduced perioperative blood loss in adults undergoing major spinal surgery.
NCT01136590.
围手术期氨甲环酸（TXA）的使用可以减少几种类型手术的出血和输血需求，但缺乏证明其在大型脊柱手术中有效性的 I 级证据。本研究旨在调查氨甲环酸可减少大型脊柱手术患者围手术期失血和输血需求的假设。
我们进行了一项多中心、前瞻性、随机、双盲临床试验，比较了 TXA 与安慰剂在后路器械固定脊柱手术中的疗效。根据输血量和围手术期失血量来确定疗效。还分析了其他变量，如手术特点、住院时间和并发症。
95 例接受后路器械固定脊柱手术（融合>3 个节段）的患者入组并随机分组：44 例接受 TXA（TXA 组），51 例接受安慰剂（对照组）。两组在手术时间、融合节段数和住院时间方面无差异。TXA 组 48%的患者无需输血，而对照组为 33%（P=0.05）。TXA 组平均输血量为 0.85 个单位，安慰剂组为 1.42 个单位（P=0.06）。与安慰剂相比，TXA 组术中出血量（P=0.01）和总出血量（P=0.01）显著减少。两组不良反应发生率相似。
TXA 并未显著减少输血需求，但可显著减少成人大型脊柱手术的围手术期失血。
NCT01136590。
