研究背景：小儿心脏手术具有较高的异体输血率，且异体输血增加围术期不良事件发生率。随着患者血液管理（patient blood management, PBM）计划的发展，血液保护概念已成为小儿心脏手术围术期医学的重要组成部分。体外循环（cardiopulmonary bypass, CPB）是小儿心脏手术的主要环节，患儿在这一环节进行PBM策略可能对预后产生积极影响。因10kg及以下的先心病低体重患儿血液管理更加复杂，将于课题组后续研究工作中体现，故本次研究将基于10kg以上心脏手术患儿的大样本临床数据探讨围CPB期实施综合血液保护策略质量管理对患儿围术期输血和临床结局的影响。

研究方法：本研究是一项回顾性研究，纳入2014年9月至2021年12月期间接受CPB心脏手术的9792名患儿（年龄≤14岁并且体重＞10kg）的医疗数据。首先根据围术期有无输注红细胞（red blood cell, RBC），将患者分为围术期未输注RBC组（n=6455）和输注RBC组(n=3337)，探讨围术期输注RBC对患儿临床结局的影响。随后，由于小儿CPB中心从2016年1月开始全面实施综合血液保护策略质量管理，根据实施综合血液保护策略质量管理前后，将患者分为传统组（n=1762）和改良组（n=8030），探讨围CPB期实施综合血液保护策略质量管理对患儿输血和临床结局的影响。收集包括基线特征、术中/术后变量和临床结局在内的数据，比较输血情况和临床结局。通过1:1倾向性评分匹配（propensity score matching, PSM）调整基线特征，并根据STAT评分、性别、紫绀型先心病、年龄和体重对患儿进行亚组分析。

研究结果：在根据围术期是否输注RBC进行分组的研究中，围术期未输注RBC组患儿和输注RBC组患儿基线特征PSM后，2421对患儿完成配对。围术期输注RBC组患儿与未输注RBC组患儿相比，术后胸腔引流量（118.0 vs 129.0 mL, P<0.001）显著增多，机械通气时间（4.0 vs 5.0 h, P<0.001）显著延长，术后PICU时间>5天发生率（3.6% vs 6.8%, P<0.001）、术后住院时间>7天发生率（39.2% vs 50.1%, P<0.001）和胸腔引流量>1000 mL发生率（0.9% vs 2.1%, P=0.001）均显著增加。在根据是否实施综合血液保护策略质量管理进行分组的研究中，传统组患儿和改良组患儿基线特征PSM后，1760对患儿完成配对。改良组患儿与传统组患儿相比，围术期RBC输注率（38.1% vs 33.6%，P=0.007）和CPB期间RBC输注率（18.2% vs 11.1%，P<0.001）均显著减少，围术期1U RBC输注率（29.3% vs 25.4, P=0.011）和CPB 期间1U RBC输注率（17.0% vs 9.6%, P<0.001）均显著减少，围术期血浆输注率（20.7% vs 16.6%, P=0.002）显著减少，100-1000 mL血浆输注率（19.9% vs 16.1%, P=0.004）显著减少，围术期平均RBC输注量（0.5 vs 0.4 U，P=0.041）和CPB期间平均RBC输注量（0.2 vs 0.1 U，P<0.001）均显著减少，围术期血浆输注量（P<0.004）显著减少，CPB预充量（29.2 vs 29.1 mL/kg, P=0.042 ）显著减少,同时术后肝损伤发生率（15.7% vs 10.5%, P<0.001）、急性肾损伤发生率（7.5% vs 5.5%, P=0.017）、肌酐水平（38.6 vs 36.4 μmol/L, P=0.001）和尿素氮水平（6.9 vs 6.3 mmol/L, P<0.001）均显著降低。但研究结果发现改良组患儿术后血红蛋白水平（110.0 vs 105.0 g/L，P<0.001）和红细胞比积水平（31.0% vs 30.4%, P<0.001）显著低于传统组。亚组分析结果表明，围CPB期实施综合血液保护策略质量管理显著降低心脏手术患儿亚组人群并发症的发生率。

研究结论：通过质量管理评价，CPB期间实施综合血液保护策略在10kg以上患儿心脏手术中是安全有效的，可以有效节约血液资源并降低患儿术后并发症。

Research background: Pediatric cardiac surgery has a higher blood transfusion rate, which is associated with increased adverse outcomes. With the evolution of patient blood management (PBM) programs, the blood conservation concept has become an important component of perioperative medicine in pediatric cardiac surgery. Cardiopulmonary bypass (CPB) represents a pivotal phase in pediatric cardiac surgery, and performing PBM strategies during this stage may have a positive effect on prognosis. The aim was to evaluate the comprehensive blood conservation strategy quality management. As the blood management of pediatric patients with congenital heart disease weighing 10kg or less are more complex, it will be investigated in the subsequent research work. Therefore, this study will explore the impact of comprehensive blood conservation strategy quality management during the CPB on perioperative blood transfusion and clinical outcomes based on a large clinical sample data of pediatric cardiac surgery weighing＞10kg.

Research Method: This retrospective study included 9792 pediatric patients (aged≤14 years and weight>10kg) who underwent cardiac surgery utilizing CPB between September 2014 and December 2021. Firstly, based on the RBC transfusion during the perioperative period, patients were divided into two groups: without RBC transfusion group (n=6455) and RBC transfusion group (n=3337). Since January 2016, the pediatric CPB center has fully implemented a comprehensive blood conservation strategy quality management protocol. Subsequently, patients were divided into two groups: the traditional group (n=1762) and the improved group (n=8030). Collect data including baseline features, intraoperative/postoperative variables, and clinical outcomes. We compared transfusion outcomes and clinical outcomes. In this study, we performed a 1:1 propensity score matching (PSM) to adjust baseline characteristics, and classified patients based on several key variables, including STAT score, gender, cyanotic congenital heart disease, age, and weight. Subsequently, a subgroup analysis was conducted to further elucidate the findings.

Research results: After PSM, 2421 pairs of patients in the perioperative period without RBC transfusion group and RBC transfusion group were paired. Compared with patients without RBC transfusion, patients in the perioperative RBC transfusion group showed a significant increase in thoracic drainage volume (118.0 vs 129.0 mL, P<0.001), postoperative PICU time>5 days (3.6% vs 6.8%, P<0.001), postoperative hospital stay>7 days (39.2% vs 50.1%, P<0.001), and thoracic drainage volume>1000 mL (0.9% vs 2.1%, P=0.001), prolonged mechanical ventilation time (4.0 vs 5.0 h, P<0.001). Secondly, after PSM, 1760 pairs of patients in the traditional group and improved groups were paired. Compared with the traditional group, during both CPB and perioperative phases, the improved group demonstrated significantly lower red blood cell (RBC) transfusion rates (perioperative: 38.1% vs 33.6%, P=0.007; CPB: 18.2% vs 11.1%, P<0.001), and 1U RBC transfusion rates (perioperative: 29.3% vs 25.4, P=0.011); CPB: 17.0% vs 9.6%, P<0.001. Moreover, the improved group displayed decreased perioperative plasma transfusion rates (20.7% vs 16.6%, P=0.002) and 100-1000 mL plasma transfusion rates (19.9% vs 16.1%, P=0.004), as well as reduced average RBC transfusion volumes (perioperative: 0.5 vs 0.4 U, P=0.041; CPB: 0.2 vs 0.1 U, P<0.001) and plasma transfusion volumes (P<0.04), Furthermore, a significant decreased was observed in priming volume (29.2 vs 29.1 mL/kg, P=0.042) and the intraoperative bleeding volume (35.0 vs 20.0 mL, P<0.001), as well as incidences of postoperative liver injury (15.7% vs 10.5%, P<0.001) and AKI (7.5% vs 5.5%, P=0.017). Postoperative levels of creatinine (38.6 vs 36.4 μmol/L, P=0.001) and urea nitrogen (6.9 vs 6.3 mmol/L, P<0.001) were also significantly reduced in the improved group. However, the research results found that the postoperative hemoglobin (110.0 vs 105.0 g/L, P<0.001) and hematocrit (31.0% vs 30.4%, P<0.001) levels in the improved group were significantly lower than those in the traditional group. The subgroup analysis revealed that the implementation of comprehensive blood conservation strategy quality management led to a significant reduction in the incidence of major complications within the subgroup population.

Research conclusion: Through quality management evaluation, the implementation of comprehensive blood conservation strategies during CPB is safe and effective in cardiac surgery for children weighing over 10kg, which can effectively save blood resources and reduce postoperative complications in children.