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

Takuma Maeda1, Yusuke Sasabuchi2, Hiroki Matsui3

  • 1Department of Anesthesiology, National Cerebral and Cardiovascular Center, Osaka, Japan; Division of Transfusion Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.

Insights

Tranexamic acid (TXA) use in pediatric cardiac surgery is linked to a higher seizure risk. However, this study found no significant differences in other adverse events or clinical outcomes between TXA and non-TXA groups.

Area of Science:

  • Pediatric Cardiac Surgery
  • Pharmacovigilance
  • Anesthesiology

Background:

  • Tranexamic acid (TXA) is used to reduce bleeding in cardiac surgery.
  • The safety profile of TXA in pediatric populations requires further investigation.
  • Potential adverse effects include seizures, thromboembolism, and renal dysfunction.

Purpose of the Study:

  • To investigate the association between tranexamic acid (TXA) use and adverse events (seizures, thromboembolism, renal dysfunction) in pediatric cardiac surgery patients.
  • To assess the impact of TXA on length of hospital stay and in-hospital mortality.

Main Methods:

  • Nationwide retrospective cohort study utilizing the Japanese Diagnosis Procedure Combination inpatient database.
  • Propensity score matching was employed to analyze data from 11,275 pediatric patients undergoing cardiac surgery with cardiopulmonary bypass (July 2010-March 2014).

Main Results:

  • Propensity-score matching created 3,739 pairs of patients.
  • A significantly higher proportion of seizures was observed in the TXA group (1.6%) compared to the non-TXA group (0.2%) (p<0.001).
  • No significant differences were found in thromboembolism, renal dysfunction, length of hospital stay, or in-hospital mortality.

Conclusions:

  • Tranexamic acid (TXA) use in pediatric cardiac surgery is associated with an increased risk of seizures.
  • The study found no significant association between TXA use and other investigated adverse events or clinical outcomes.
Abstract

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