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Safety of Tranexamic Acid During Pediatric Trauma: A Nationwide Database Study*

Maeda, Takuma MD, MPH, PhD1,2; Michihata, Nobuaki MD, MPH3; Sasabuchi, Yusuke MD, MPH, PhD4; Matsui, Hiroki MPH5; Ohnishi, Yoshihiko MD1; Miyata, Shigeki MD, PhD2; Yasunaga, Hideo MD, PhD5

Pediatric Critical Care Medicine: December 2018 - Volume 19 - Issue 12 - p e637-e642
doi: 10.1097/PCC.0000000000001724
Online Clinical Investigations
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Objectives: The present study aimed to examine the association between tranexamic acid use and adverse effects (seizures, thromboembolism, and renal dysfunction) in a pediatric trauma population using a national inpatient database in Japan. We also assessed the association between tranexamic acid use and in-hospital mortality.

Design: A nationwide, retrospective cohort study using propensity score analyses.

Setting: Japanese Diagnosis Procedure Combination inpatient database.

Patients: Pediatric patients less than or equal to 12 years old admitted in hospital with the diagnosis of trauma between July 2010 and March 2014 (n = 61,779).

Interventions: None.

Measurements and Main Results: Propensity score matching created 1,914 pairs of patients with and without tranexamic acid administration. Propensity-matched analysis showed that the proportion of seizures was significantly higher in the tranexamic acid group than in the nontranexamic acid group (7/1,914, 0.37% vs 0/1,914, 0%; difference, 0.37%; 95% CI, 0.10–0.64; p = 0.008). However, none of the other outcomes were significantly different between the groups.

Conclusions: Tranexamic acid use is associated with a significantly increased risk of seizures. However, no difference exists among any other outcomes between the tranexamic acid and nontranexamic acid groups.

1Department of Anesthesiology, National Cerebral and Cardiovascular Center, Osaka, Japan.

2Division of Transfusion Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.

3Department of Health Services Research, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.

4Data Science Center, Jichi Medical University, Shimotsuke, Tochigi, Japan.

5Department of Clinical Epidemiology and Health Economics School of Public Health, The University of Tokyo, Tokyo, Japan.

*See also p. 1177.

Supported, in part, by grants from the Ministry of Health, Labor and Welfare, Japan, and the Research Grant on Regulatory Science of Pharmaceuticals and Medical Devices from the Japan Agency for Medical Research and Development.

Mr. Matsui’s institution received funding from the Ministry of Health, Labour and Welfare, Japan (grants H29-Policy-Designated-009, H29-ICT-General-004, and H29-Medicine-General-008) and the Ministry of Education, Culture, Sports, Science and Technology, Japan (grants 17H04141 and 17H05077). Dr. Miyata’s institution received funding from the Research Grant on Regulatory Science of Pharmaceuticals and Medical Devices from Japan Agency for Medical Research and Development. Dr. Yasunaga’s institution received funding from Ministry of Health, Labour and Welfare, Japan. The remaining authors have disclosed that they do not have any potential conflicts of interest.

Address requests for reprints to: Takuma Maeda, MD, MPH, PhD, Division of Transfusion Medicine, Department of Anesthesiology, National Cerebral and Cardiovascular Center, 5-7-1 Fujishirodai, Suita, Osaka 565–8565, Japan. E-mail: takuma@ncvc.go.jp

Copyright © 2018 by the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies