Background: Although intravenous tranexamic acid is used in cardiac surgery to reduce bleeding and transfusion, topical tranexamic acid results in lower plasma concentrations compared to intravenous tranexamic acid, which may lower the risk of seizures. We aimed to determine whether topical tranexamic acid reduces the risk of in-hospital seizure without increasing the risk of transfusion among cardiac surgery patients.Methods: We conducted a multicenter, double dummy, blinded, randomized controlled trial of patients recruited by convenience sampling in academic hospitals undergoing cardiac surgery with cardiopulmonary bypass. Between September 17, 2019, and November 28, 2023, a total of 3242 patients from 16 hospitals in 6 countries were randomly assigned (1:1 ratio) to receive either intravenous tranexamic acid (control) through surgery or topical tranexamic acid (treatment) at the end of surgery. The primary outcome was seizure, and the secondary outcome was red blood cell transfusion. After the last planned interim analysis―when 75% of anticipated participants had completed follow up―the Data and Safety Monitoring Board recommended to terminate the trial, and upon unblinding, the Operations Committee stopped the trial for safety.Results: Among 3242 randomized patients (mean age, 66.0 years; 77.7% male), in-hospital seizure occurred in 4 of 1624 patients (0.2%) in the topical group and in 11 of 1628 patients (0.7%) in the intravenous group (absolute risk difference, -0.5%; 95% CI, -0.9 to 0.03; P = .07). Red blood cell transfusion occurred in 570 patients (35.1%) in the topical group and in 433 (26.8%) in the intravenous group (absolute risk difference, 8.3%; 95% CI, 5.2 to 11.5; P = .007). The absolute risk difference in transfusion of ≥4 units of red blood cells in the topical group compared to the intravenous group was 8.2% (95% CI, 3.4 to 12.9).Conclusions: Among patients having cardiac surgery, topical administration of tranexamic acid resulted in an 8.3% absolute increase in transfusion without reducing the incidence of seizure, compared to intravenous tranexamic acid.

中文翻译：

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接受心脏手术的患者局部使用氨甲环酸与静脉注射氨甲环酸：DEPOSITION 随机对照试验

背景：虽然静脉注射氨甲环酸用于心脏手术以减少出血和输血，但与静脉注射氨甲环酸相比，局部氨甲环酸导致血浆浓度较低，这可能会降低癫痫发作的风险。我们的目的是确定局部氨甲环酸是否可以降低心脏手术患者院内癫痫发作的风险，而不增加输血风险。方法：我们对学术界方便抽样招募的患者进行了一项多中心、双模拟、盲法、随机对照试验。进行体外循环心脏手术的医院。 2019年9月17日至2023年11月28日期间，来自6个国家16家医院的总共3242名患者被随机分配（1:1比例）接受通过手术静脉注射氨甲环酸（对照）或局部氨甲环酸（治疗）在手术结束时。主要结局是癫痫发作，次要结局是红细胞输注。在最后一次计划的中期分析之后——当 75% 的预期参与者完成随访时——数据和安全监测委员会建议终止试验，在揭盲后，运营委员会出于安全考虑停止了试验。结果：在 3242 名随机患者中（平均年龄，66.0 岁；77.7% 男性），外用组 1624 名患者中有 4 名（0.2%）发生院内癫痫发作，静脉注射组 1628 名患者中有 11 名（0.7%）发生院内癫痫发作（绝对风险差异，-0.5） %；95% CI，-0.9 至 0.03；P = .07）。局部治疗组有 570 名患者 (35.1%) 进行了红细胞输注，静脉注射组有 433 名患者 (26.8%) 进行了红细胞输注（绝对风险差异，8.3%；95% CI，5.2 至 11.5；P = .007）。与静脉注射组相比，局部组输注 ≥4 单位红细胞的绝对风险差异为 8.2%（95% CI，3.4 至 12.9）。结论：在接受心脏手术的患者中，局部给予氨甲环酸导致与静脉注射氨甲环酸相比，输血量绝对增加了 8.3%，但并未降低癫痫发作的发生率。