Painter Thomas W, McIlroy David, Myles Paul S, Leslie Kate
1 Department of Anaesthesia, Royal Adelaide Hospital, Adelaide, Australia.
2 Discipline of Acute Care Medicine, Adelaide Medical School, University of Adelaide, Adelaide, Australia.
Anaesth Intensive Care. 2019 Jan;47(1):76-84. doi: 10.1177/0310057X18811977. Epub 2019 Feb 13.
Major bleeding in noncardiac surgery is common and associated with serious complications. The antifibrinolytic agent tranexamic acid (TXA) reduces bleeding and may reduce the risk of these complications. TXA also may have immunomodulatory effects that could reduce surgical site infection. Clinical trials of TXA in noncardiac surgery have been insufficiently powered to evaluate its efficacy and safety. Therefore, large randomised controlled trials of its use in noncardiac surgery are required. To ensure that future clinical trials are feasible and acceptable, we undertook a survey of Fellows of the Australian and New Zealand College of Anaesthetists (ANZCA). Our aims were to ascertain current patterns of TXA administration and to assess the acceptability of randomising patients to intravenous TXA or placebo. A 12-item survey was electronically mailed to 1001 ANZCA Fellows. Two hundred and eighty nine responses were received and analysed (response rate 29%). Ninety-eight percent of respondents had used intravenous TXA in noncardiac surgery; 67% give TXA routinely for lower limb arthroplasty, with smaller proportions giving TXA for spinal surgery (40%) and other major orthopaedic surgery (28%). Almost half (49%) give TXA routinely for major trauma surgery. Thirty-six percent indicated that they did not give TXA for major vascular, abdominal, pelvic or thoracic surgery. The majority administered TXA as a single, fixed dose. Fifty-seven percent agreed that there is uncertainty about the relative risks and benefits of perioperative TXA in noncardiac surgery and 87% agreed that large definitive trials determining the safety and efficacy of perioperative TXA in noncardiac surgery are required. These results indicate that for ANZCA Fellows the use of TXA in noncardiac surgery is highly variable, that there is uncertainty about the safety and efficacy of TXA, and that a large trial would be acceptable.
非心脏手术中的大出血很常见，且与严重并发症相关。抗纤维蛋白溶解剂氨甲环酸（TXA）可减少出血，并可能降低这些并发症的风险。TXA还可能具有免疫调节作用，从而降低手术部位感染的风险。TXA在非心脏手术中的临床试验样本量不足，无法评估其疗效和安全性。因此，需要开展大规模随机对照试验来研究其在非心脏手术中的应用。为确保未来的临床试验可行且可接受，我们对澳大利亚和新西兰麻醉师学院（ANZCA）的会员进行了一项调查。我们的目的是确定当前TXA的给药模式，并评估将患者随机分配接受静脉注射TXA或安慰剂的可接受性。一项包含12个项目的调查问卷通过电子邮件发送给了1001名ANZCA会员。共收到289份回复并进行了分析（回复率29%）。98%的受访者在非心脏手术中使用过静脉注射TXA；67%的受访者在下肢关节置换术中常规使用TXA，在脊柱手术（40%）和其他大型骨科手术（28%）中使用TXA的比例相对较小。近一半（49%）的受访者在重大创伤手术中常规使用TXA。36%的受访者表示他们在重大血管、腹部、盆腔或胸部手术中不使用TXA。大多数人将TXA作为单一固定剂量给药。57%的受访者认为围手术期使用TXA在非心脏手术中的相对风险和益处尚不确定，87%的受访者认为需要开展大规模确定性试验来确定围手术期TXA在非心脏手术中的安全性和疗效。这些结果表明，对于ANZCA会员而言，TXA在非心脏手术中的使用差异很大，TXA的安全性和疗效尚不确定，并且开展一项大型试验是可以接受的。
