Safety of Tranexamic Acid in Pediatric Cardiac Surgery: A Nationwide Database Study.

Objectives The present study aimed to examine the association between tranexamic acid (TXA) use and adverse effects (seizures, thromboembolism, and renal dysfunction) in a pediatric cardiac surgery population using a national inpatient database in Japan. The authors also assessed the association between TXA use and other clinical outcomes (length of hospital stay and in-hospital mortality). Design A nationwide, retrospective cohort study using propensity score analyses. Setting Japanese Diagnosis Procedure Combination inpatient database. Participants Pediatric patients who underwent cardiac surgery using cardiopulmonary bypass between July 2010 and March 2014 (N = 11,275). Interventions None. Measurements and Main Results Propensity-score matching created 3,739 pairs of patients with and without TXA administration. Propensity-matched analysis showed that the proportion of seizures was significantly higher in the TXA group than in the non-TXA group (1.6% v 0.2%, difference, 1.4%; 95% confidence interval, 1.0-1.9; p<0.001). However, none of the other outcomes was significantly different between the groups. Conclusions TXA use is associated with a significantly increased risk of seizures. However, there is no difference in any other outcomes between the TXA and non-TXA groups. [ABSTRACT FROM AUTHOR]