早期给予纤维蛋白原、凝血酶原复合物和血小板预防小儿复杂心脏手术术后出血:一项前瞻性观察研究

2021

01/13

米勒之声

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本文由“罂粟花”授权转载

早期给予纤维蛋白原、凝血酶原复合物和血小板预防小儿复杂心脏手术术后出血:一项前瞻性观察研究

背景

术后出血是小儿接受复杂心脏手术的主要问题。此项前瞻性观察研究的主要目的是评估本机构常规早期预防性结合使用纤维蛋白原、凝血酶原复合物和血小板对儿童凝血参数和术后出血的影响。次要指标是研究再干预率和术后输血率、血栓发生率、机械通气时间、ICU住院时间和死亡率。

方法

50名儿童(0-6岁)合并一个或多个预估体外循环(CPB)术后出血危险因素，基础时点(T1)、CPB结束和肝素逆转后(T2)、胸骨关闭后(T3)以及入ICU 12小时后 (T4)测量血栓弹力图(TEG)和标准凝固参数。临床出血量由外科医生在T2和T3时点使用数值评定量表(NRS, 0-10)进行评估。

结果

早期给予纤维蛋白原、凝血酶原复合物和血小板后至CPB结束，临床出血评价数值由T2时点的平均6.2±1.9 (NRS)下降到T3时点的平均2.1±0.8 (NRS;P＜0.001)。血栓弹力图监测中反应时间(R)、动力学时间(K)、最大振幅(MA)和纤维原最大振幅(MA-fib)均明显改善(P值均＜0.001），MA-fib与临床出血评价显著相关(r=0.70,P＜0.001)。纤维蛋白原输注总量(mg kg^-1)与下列因素显著相关：包括，体重(r=-0.42, P=0.002),灌注量占估计血容量的百分比(r=0.30, P=0.034),CPB期间最低温度(r = 0.30, P=0.033)和T2到T3时点临床预估出血的变化(r=0.71,P＜0.001)。术后出血发生率为8%(出血量＞估计血容量的10%)。没有患儿需要再次手术止血，没有观察到血栓形成。院内死亡率为0%。

结论

此项观察研究针对的是体外循环后出血风险增加儿童,遵循临床出血量和TEG评估早期预防性给予纤维蛋白原、凝血酶原复合物和血小板治疗可显著减少出血量、改善TEG和标准凝血参数,且没有发生再次手术止血和血栓形成相关的并发症。

Prevention of postoperative bleeding after complex pediatric cardiac surgery by early administration of fibrinogen, prothrombin complex and platelets: a prospective observational study

Abstract

Background: 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.

Methods: 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).

Results: 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⁻¹ ) 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%.

Conclusion: 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.