Clinic for Anaesthesiology and Intensive Care Medicine, Hannover Medical School, OE 8050, Carl-Neuberg-Str. 1, D-30625, Hannover, Germany.
Clinic for Cardiac, Thoracic, Transplant and Vascular Surgery, Hannover Medical School, Carl-Neuberg-Str. 1, D-30625, Hannover, Germany.
BMC Anesthesiol. 2020 Dec 18;20(1):302. doi: 10.1186/s12871-020-01217-1.
Postoperative bleeding is a major problem in children undergoing complex pediatric cardiac surgery. The primary aim of this prospective observational study was to evaluate the effect of an institutional approach consisting of early preventive fibrinogen, prothrombin complex and platelets administration on coagulation parameters and postoperative bleeding in children. The secondary aim was to study the rate of re-intervention and postoperative transfusion, the occurrence of thrombosis, length of mechanical ventilation, ICU stay and mortality.
In fifty children (age 0-6 years) with one or more predefined risk factors for bleeding after cardiopulmonary bypass (CPB), thrombelastography (TEG) and standard coagulation parameters were measured at baseline (T1), after CPB and reversal of heparin (T2), at sternal closure (T3) and after 12 h in the ICU (T4). Clinical bleeding was evaluated by the surgeon at T2 and T3 using a numeric rating scale (NRS, 0-10).
After CPB and early administration of fibrinogen, prothrombin complex and platelets, the clinical bleeding evaluation score decreased from a mean value of 6.2 ± 1.9 (NRS) at T2 to a mean value of 2.1 ± 0.8 at T3 (NRS; P < 0.001). Reaction time (R), kinetic time (K), maximum amplitude (MA) and maximum amplitude of fibrinogen (MA-fib) improved significantly (P < 0.001 for all), and MA-fib correlated significantly with the clinical bleeding evaluation (r = 0.70, P < 0.001). The administered total amount of fibrinogen (mg kg) correlated significantly with weight (r = - 0.42, P = 0.002), priming volume as percentage of estimated blood volume (r = 0.30, P = 0.034), minimum CPB temperature (r = - 0.30, P = 0.033) and the change in clinical bleeding evaluation from T2 to T3 (r = 0.71, P < 0.001). The incidence of postoperative bleeding (> 10% of estimated blood volume) was 8%. No child required a surgical re-intervention, and no cases of thrombosis were observed. Hospital mortality was 0%.
In this observational study of children with an increased risk of bleeding after CPB, an early preventive therapy with fibrinogen, prothrombin complex and platelets guided by clinical bleeding evaluation and TEG reduced bleeding and improved TEG and standard coagulation parameters significantly, with no occurrence of thrombosis or need for re-operation.
German Clinical Trials Register DRKS00018109 (retrospectively registered 27th August 2019).
术后出血是儿童接受复杂儿科心脏手术后的一个主要问题。本前瞻性观察研究的主要目的是评估一种机构方法的效果，该方法包括早期预防性纤维蛋白原、凝血酶原复合物和血小板给药对儿童凝血参数和术后出血的影响。次要目的是研究再次干预和术后输血的发生率、血栓形成的发生、机械通气时间、重症监护病房住院时间和死亡率。
在 50 名（0-6 岁）有一个或多个体外循环（CPB）后出血风险因素的儿童中，在基线（T1）、CPB 后和肝素逆转（T2）、胸骨闭合（T3）和 ICU 后 12 小时（T4）时测量血栓弹力图（TEG）和标准凝血参数。在 T2 和 T3 时，由外科医生使用数字评分量表（NRS，0-10）评估临床出血情况。
CPB 后和早期给予纤维蛋白原、凝血酶原复合物和血小板后，临床出血评估评分从 T2 的平均 6.2±1.9（NRS）降至 T3 的平均 2.1±0.8（NRS；P<0.001）。反应时间（R）、动力学时间（K）、最大振幅（MA）和纤维蛋白原最大振幅（MA-fib）显著改善（所有 P<0.001），MA-fib 与临床出血评估显著相关（r=0.70，P<0.001）。给予的纤维蛋白原总量（mg·kg）与体重显著相关（r=-0.42，P=0.002）、预充量占估计血容量的百分比（r=0.30，P=0.034）、最低 CPB 温度（r=-0.30，P=0.033）和 T2 至 T3 期间临床出血评估的变化（r=0.71，P<0.001）。术后出血（>10%估计血容量）的发生率为 8%。没有儿童需要再次手术干预，也没有观察到血栓形成。住院死亡率为 0%。
在本项 CPB 后出血风险增加的儿童观察性研究中，基于临床出血评估和 TEG 的纤维蛋白原、凝血酶原复合物和血小板早期预防性治疗显著减少了出血，并显著改善了 TEG 和标准凝血参数，无血栓形成或需要再次手术。
德国临床试验注册处 DRKS00018109（2019 年 8 月 27 日回顾性注册）。
