iac operations with CPB. This prospective, multicenter, randomized, double-blind, placebo-controlled study was designed to evaluate the safety and efficacy of preoperative treatment with AT supplementation in patients at risk for low AT activity after undergoing cardiac surgery with CPB. METHODS: A total of 425 adult patients were randomized (1:1) to receive either a single dose of AT (n = 213) to achieve an absolute increase of 20% above pretreatment AT activity or placebo (n = 212) before surgery. The study duration was approximately 7 weeks. The primary efficacy end point was the percentage of patients with any component of a major morbidity composite (postoperative mortality, stroke, acute kidney injury [AKI], surgical reexploration, arterial or venous thromboembolic events, prolonged mechanical ventilation, and infection) in the 2 groups. Secondary end points included AT activity, blood loss, transfusion requirements, duration of intensive care unit (ICU), and hospital stays. Safety was also assessed. RESULTS: Overall, 399 patients (men, n = 300, 75.2%) with a mean (standard deviation [SD]) age of 66.1 (11.7) years, with the majority undergoing complex surgical procedures (n = 266, 67.9%), were analyzed. No differences in the percentage of patients experiencing morbidity composite outcomes between groups were observed (AT-treated 68/198 [34.3%] versus placebo 58/194 [29.9%]; P = .332; relative risk, 1.15). After AT infusion, AT activity was significantly higher in the AT group (108% [42–143]) versus placebo group (76% [40–110]), and lasted up to postoperative day 2. At ICU, the frequency of patients with AT activity ≥58% in the AT group (81.5%) was significantly higher (P < .001) versus placebo group (43.2%). Secondary end point analysis did not show any advantage of AT over placebo group. There were significantly more patients with AKI (P < .001) in the AT group (23/198; 11.6%) than in the placebo group (5/194, 2.6%). Safety results showed no differences in treatment-emergent adverse events nor bleeding events between groups. CONCLUSIONS: AT supplementation did not attenuate adverse postoperative outcomes in our cohort of patients undergoing cardiac surgery with CPB....

中文翻译：

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一项多中心、随机、双盲、安慰剂对照试验，在心脏手术后有抗凝血酶缺乏风险的患者中进行术前补充抗凝血酶的试验

与 CPB 的 iac 操作。这项前瞻性、多中心、随机、双盲、安慰剂对照研究旨在评估在接受 CPB 心脏手术后有低 AT 活动风险的患者术前补充 AT 治疗的安全性和有效性。方法：共有 425 名成年患者被随机化 (1:1) 接受单剂量 AT (n = 213) 以达到治疗前 AT 活性绝对增加 20% 或安慰剂 (n = 212)。研究持续时间约为 7 周。主要疗效终点是在 2团体。次要终点包括 AT 活动、失血量、输血需求、重症监护病房 (ICU) 的持续时间和住院时间。还评估了安全性。结果：总体而言，399 名患者（男性，n = 300, 75.2%），平均（标准差 [SD]）年龄为 66.1（11.7）岁，其中大多数接受了复杂的外科手术（n = 266, 67.9%），进行了分析。未观察到组间经历发病率复合结局的患者百分比存在差异（AT 治疗组 68/198 [34.3%] 与安慰剂组 58/194 [29.9%]；P = .332；相对风险，1.15）。输注 AT 后，AT 组 (108% [42–143]) 的 AT 活性显着高于安慰剂组 (76% [40–110])，并持续到术后第 2 天。 AT 活性≥58% 的 AT 组（81.5%）显着升高（P < . 001) 与安慰剂组 (43.2%)。次要终点分析未显示 AT 优于安慰剂组。AT 组 (23/198; 11.6%) 的 AKI 患者 (P < .001) 明显多于安慰剂组 (5/194, 2.6%)。安全性结果显示，治疗中出现的不良事件和出血事件在各组之间没有差异。结论：在我们接受 CPB 心脏手术的患者队列中，AT 补充剂并未减轻不良的术后结果。安全性结果显示，治疗中出现的不良事件和出血事件在各组之间没有差异。结论：在我们接受 CPB 心脏手术的患者队列中，AT 补充剂并未减轻不良的术后结果。安全性结果显示，治疗中出现的不良事件和出血事件在各组之间没有差异。结论：在我们接受 CPB 心脏手术的患者队列中，AT 补充剂并未减轻不良的术后结果。