الفهرس 
INTRODUCTIONOnly 14 pages are availabe for public view
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Abstract
Trauma, one of the most leading causes of death in people younger than 40 years, with hemorrhage accounting for death in 30% of them. The impact of trauma cannot be represented with mortality data alone. In children, injuries are the leading cause of emergency department visits, and 225,000 hospital admissions. Early recognition and prompt treatment of life-threatening airway, inadequate breathing, and hemorrhage significantly decrease mortality rates after major trauma.
Tranexamic acid (TXA) was initially described 1966 and used to control hemorrhage that stems from dental, menstrual bleeding, and alter intra-operative hemodynamics. TXA, an antifibrinolytic drug, has been evaluated as a therapeutic option in some indications as trauma, traumatic brain injury, intracranial hemorrhage, gastrointestinal bleeding, and epistaxis.
TXA is a cornerstone option of hemostatic resuscitation in adult literature. Data from pediatric studies is more limited, most of the literature documenting TXA use in spinal, craniofacial and cardiac surgeries only.
The aim of this study is to evaluate the effect of early use of tranexamic acid (TXA) on outcomes of pediatric trauma patients in the Emergency Department. In this study, ninety pediatric trauma patients (n=90) who were enrolled. Patients who need immediate surgical intervention, with known hypersensitivity to TXA, thrombophilia, burns or fatal head traumas were excluded. Enrolled patients were randomized to receive IV TXA (TXA group, 45) or placebo (control group, 45). The primary outcome was the 24-hour blood product administration. The secondary outcomes were in-hospital mortality and adverse events.
Regarding baseline characteristics, the mean age of all patients was 9.1 ± 2.801 years. Males (60%) was more represented than females (40%). Road traffic accident (RTA) was the most prevalent mode of trauma (43.3%)
Regarding the secondary outcome of this study, TXA was not associated with mortality benefit after 24 hours (p =0.315) but, it was associated with significantly lower in-hospital mortality rate (11.1 % Vs. 35.6%, p =0.012) than placebo. After controlling for confounders, only administration of TXA was independently associated with reduced in-hospital mortality (OR= 0.231; 95% CI, 0.065-0.824; p = 0.024).
Regarding the adverse effects of TXA, the most common adverse effects were renal dysfunction (13.3%), GIT upset (8.9%), seizures (6.6%) and drug-related hypersensitivity reactions (6.6%). Although this high incidence of renal dysfunction in TXA, it was nearly similar to the incidence in control group (12%). TXA was generally safe, well tolerated, and no major events were recorded.
Because of the small sample size, monocentric design, and the number of adverse events in the study was too small, direct statistical comparison between the two groups was not done. Some observations were too small to assess any independent risk of TXA. Otherwise, after controlling for confounders, mortality benefit was observed with TXA. This mortality benefit may outweight risks of using such agent in this study.
In the context of our results, early tranexamic acid may be a safe and effective therapeutic option in pediatric trauma patients during their Emergency Department (ED) stay as benefit may outweigh its risk. It may not reduce the need for massive transfusion directly, but it has an independent late mortality benefit as in adults.