Hospital Policy of Tranexamic Acid to Reduce Transfusion in Major Noncardiac Surgery.

Methods

We conducted a multicenter, double-blind, cluster-randomized, placebo-controlledtrial involving patients undergoing noncardiac surgery who were at high risk for red-cell transfusion.

我们进行了一项多中心、双盲、群组随机、安慰剂对照试验，涉及接受非心脏手术且红细胞输注风险高的患者。

Hospitals were randomly assigned at 4-week intervals to a hospital-wide policy of intraoperative tranexamic acid or placebo.

医院每4周随机分配到全院范围内的手术中使用氨甲环酸或安慰剂的政策。

The coprimary effectiveness and safety outcomes were transfusion of red cells during the index hospitalization and diagnosis of venous thromboembolism within 90 days, respectively.

主要的有效性和安全性结果分别是指数住院期间的红细胞输注和90天内诊断出的静脉血栓栓塞症。

The safety outcome was assessed for noninferiority, with a prespecified noninferiority margin defined as an upper boundary of 1.46 for the 95% confidence intervalof the relative risk.

安全性结果通过非劣效性评估，预设的非劣效性边界定义为相对风险的95%置信区间的上限为1.46。

Analyses used mixed-effects models that accounted for the cluster-crossover design.

分析使用了混合效应模型，该模型考虑了群组交叉设计。

Results

A total of 8273 patients enrolled across 10 Canadian hospitals could be evaluated for the coprimary outcomes.

共有8273名患者在10家加拿大医院注册，可用于评估共同主要结果。

Oncologic surgery accounted for 60.5% of the surgical procedures (5002 of 8273).

肿瘤外科手术占所有手术程序的60.5%（8273例中的5002例）。

The percentage of patients who received a red-cell transfusion during hospitalization was 7.4% (306 of 4156) in the tranexamic acid group and 9.8% (403 of 4117) in the placebo group (relative risk, 0.73; 95% confidence interval[CI], 0.61 to 0.86; adjusted difference, -2.7 percentage points; 95% CI, -4.2 to -1.4).

住院期间接受红细胞输血的患者比例在氨甲环酸组为7.4%（306/4156），安慰剂组为9.8%（403/4117）（相对风险，0.73；95%置信区间[CI]，0.61至0.86；调整后差异，-2.7个百分点；95% CI，-4.2至-1.4）。

Venous thromboembolism within 90 days occurred in 2.1% of patients (86 of 4128) in the tranexamic acid group and 2.1% of patients (85 of 4052) in the placebo group (relative risk, 0.96; 95% CI, 0.65 to 1.38; adjusted difference, -0.1 percentage points; 95% CI, -0.9 to 0.7), which met the criterion for noninferiority.

90天内，氨甲环酸组有2.1%的患者（86/4128）和安慰剂组有2.1%的患者（85/4052）发生了静脉血栓栓塞（相对风险，0.96；95% CI，0.65至1.38；调整后差异，-0.1个百分点；95% CI，-0.9至0.7），这满足了非劣效性的标准。

Conclusions

Among patients undergoing major noncardiac surgery, a hospital policy of tranexamic acid administration resulted in a lower incidenceof red-cell transfusion than placebo administration, and tranexamic acid was noninferior to placebo with regard to diagnosis of venous thromboembolism.

在接受重大非心脏手术的患者中，实施氨甲环酸给药的医院政策使得红细胞输注的发生率低于安慰剂给药，并且氨甲环酸在诊断静脉血栓栓塞症方面与安慰剂相比显示出非劣效性。

(Funded by the Canadian Institutes of Health Research and others; TRACTION ClinicalTrials.gov number, NCT04803747.).

（由加拿大卫生研究院等资助；TRACTION ClinicalTrials.gov编号，NCT04803747。）