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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.
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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