Bigdelian Hamid, Montazeri Minoo, Sedighi Mohsen, Mansouri Mojtaba, Amanollahi Alireza
Department of Cardiovascular Surgery, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.
Trauma and Injury Research Center, Iran University of Medical Sciences, Tehran, Iran.
J Surg Res. 2023 Aug;288:64-70. doi: 10.1016/j.jss.2023.02.029. Epub 2023 Mar 20.
Postoperative bleeding is a common complication in congenital heart surgery. We aimed to evaluate effects of topical and intravenous tranexamic acid (TXA) administration on postoperative hemoglobin and bleeding in children with acyanotic congenital heart disease (CHD).
In this randomized clinical trial, 50 acyanotic CHD children were allocated into two groups of topical (n = 25) and infusion (n = 25). Children in the infusion group were given intravenous TXA 50 mg/kg after sternotomy. Children in topical group were given 50 mg/kg TXA added to 20 mL of saline intrapericardially before sternal closure. Primary endpoint of study was comparison of postoperative hemoglobin and bleeding between topical and infusion groups. A linear mixed model (LMM) was used to estimate longitudinal changes in postoperative endpoints.
We did not observe significant differences in children's characteristics between two groups. Also, intraoperative and postoperative outcomes did not differ between two groups but children with intravenous TXA experienced significantly longer intubation time than topical children (P = 0.047). LMM analysis revealed that postoperative bleeding in topical group was lower compared to infusion group (P = 0.036). Also, age of children had a significant effect on mean changes of hemoglobin during postoperative care (β = -0.27, P = 0.030). No children died and none had serious postoperative complications such as seizures and reoperation.
We found that topical TXA is not superior to intravenous administration in management of blood loss. Also, no additional effect was found about topical TXA in further reducing transfusion rates and postoperative complications in acyanotic CHD children undergoing cardiac surgery.
术后出血是先天性心脏病手术中常见的并发症。我们旨在评估局部和静脉注射氨甲环酸（TXA）对非紫绀型先天性心脏病（CHD）患儿术后血红蛋白和出血情况的影响。
在这项随机临床试验中，50名非紫绀型CHD患儿被分为局部用药组（n = 25）和静脉输注组（n = 25）。静脉输注组的患儿在胸骨切开术后静脉注射50 mg/kg TXA。局部用药组的患儿在胸骨闭合前在心包内给予加入20 mL生理盐水的50 mg/kg TXA。研究的主要终点是比较局部用药组和静脉输注组术后的血红蛋白和出血情况。采用线性混合模型（LMM）来估计术后终点的纵向变化。
我们未观察到两组患儿在特征上的显著差异。此外，两组在术中及术后的结果并无差异，但静脉注射TXA的患儿插管时间明显长于局部用药的患儿（P = 0.047）。LMM分析显示，局部用药组的术后出血量低于静脉输注组（P = 0.036）。此外，患儿年龄对术后护理期间血红蛋白的平均变化有显著影响（β = -0.27，P = 0.030）。没有患儿死亡，也没有患儿出现癫痫发作和再次手术等严重术后并发症。
我们发现局部使用TXA在控制失血方面并不优于静脉给药。此外，在进一步降低接受心脏手术的非紫绀型CHD患儿的输血率和术后并发症方面，未发现局部使用TXA有额外效果。
