Efficacy And Safety Study Of Tranexamic Acid In Pediatric Cardiac Surgery

Objective:Congenital heart disease(CHD)has been associated with low levels of fibrinogen and activation of fibrinolysis during the process of cardiopulmonary bypass.Therefore,pediatric patients undergoing cardiac surgery are at high risk of bleeding.Compared with adults,children with low body weight have less systemic blood volume;therefore,the proportion of bleeding to systemic blood volume is relatively high and the incidence of allogeneic blood transfusion is increased in pediatric patients undergoing cardiac surgery.Moreover,allogeneic blood transfusion may increase postoperative morbidity and mortality.At present,tranexamic acid has become the main anti-fibrinolytic drug to prevent blood loss in adult cardiac surgery,however,research on the application of tranexamic acid in pediatric cardiac surgery is still limited.This study evaluated the efficacy and safety of tranexamic acid in pediatric patients undergoing cardiac surgery.Methods:Using a retrospective cohort study design,2026 consecutive patients aged from 31 days to 12 years old who underwent primary surgical repair of atrial or ventricular septal defect or complete repair of Tetralogy of Fallot during January 2009 to December 2010,were enrolled in the study.They were divided into two groups:the control group(n=1056)and the tranexamic acid group(n=970).Infant was identified as pediatric patients aged 31 days to 1 year old.The amount of perioperative bleeding,the postoperative volume or exposure of allogeneic blood transfusion,morbidity and mortality were recorded and analyzed.Results:Compared with that in the control group,there were statistically significant reduction of both the 12-h and total postoperative bleeding in the tranexamic acid group[6.573±0.144 vs.5.499±0.133 ml kg-1,mean difference(MD)1.074 ml kg-1,p<0.001;12.183±0.298 vs.9.973±0.276 ml kg-1,MD,2.210 ml kg-1,p<0.001].There was a statistically significant reduction of the the MD of 12-h postoperative bleeding due to tranexamic acid in patients aged<1 year compared with that in patients aged≥1 year(MD,1.461 vs.0.704 ml kg-1,P=0.007).There were statistically significant reduction of the MD of both the 12-h and total postoperative bleeding due to tranexamic acid in patients weighing<10 kg compared with that in patients weighing ≥10 kg(MD,1.513 vs.0.454 ml kg-1,P<0.001,and MD,2.165 vs.0.947 ml kg-1,P=0.036,respectively).There was a statistically significant reduction of the MD of total postoperative bleeding due to tranexamic acid in cyanotic patients compared with that in acyanotic patients(MD,3.314 vs.1.037 ml kg-1,P=0.002).There was no significant difference in the postoperative volume or exposure of allogeneic blood transfusion between the two groups.Subgroup analysis suggested that tranexamic acid reduced allogeneic blood transfusion in terms of the red blood cell exposure(27.18 vs.19.14%,p=0.044),fresh frozen plasma volume(31.906±3.603 vs.15.916±3.955 ml,p=0.003)and fresh frozen plasma exposure(28.72 vs.13.58%,p<0.001)in patients aged<1 year undergoing repair surgery for ventricular septal defect;Moreover,tranexamic acid had no effect on the volume and exposure of allogeneic blood transfusion in children undergoing complete surgery for tetralogy of Fallot(p>0.05).Furthermore,There was no significant difference in in-hospital morbidity or mortality between the two groups.Conclusions:Tranexamic acid took effects in reduction of postoperative bleeding in pediatric patients undergoing cardiac surgery,particularly in infants,pediatric patients weighing<10 kg and cyanotic children.Moreover,tranexamic acid had no effect on the allogeneic blood transfusion requirement in pediatric cardiac surgery,however,tranexamic acid took effects in reduction of postoperative allogeneic blood transfusion in infants undergoing cardiac surgery.Furthermore,the study suggested the use of tranexamic acid was safe in pediatric cardiac surgery.