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.
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