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Tranexamic acid dosing in pediatric trauma: Dose simulation based on population pharmacokinetic modeling in adult
Gideon Stitt1, Kevin Downes2,3,4, Athena Zuppa4
1Division of Clinical Pharmacology, Department of Pediatrics, University of Utah, Salt Lake City, Utah, USA.
Insights
A 25 mg/kg IV bolus of tranexamic acid (TXA) in pediatric trauma patients approximates adult Cmax. However, more frequent dosing may be needed for similar total drug exposure in children with trauma-related bleeding.
Area of Science:
- Pediatric Trauma Care
- Pharmacokinetics
- Hemorrhage Management
Background:
- Trauma is a leading cause of death in children over one year old.
- Hemorrhage is the most common preventable cause of death following pediatric trauma.
- Optimal dosing of antifibrinolytics like tranexamic acid (TXA) in children is unknown.
Purpose of the Study:
- To determine a TXA dose for pediatric trauma patients that mimics adult exposure.
- Utilize a population pharmacokinetic (popPK) model from adult trauma patients.
Main Methods:
- Model-based simulation extrapolating an adult TXA popPK model to pediatric patients.
- Simulated a virtual pediatric trauma population using covariate values.
- Applied allometric scaling to predict TXA PK profile in children.
Main Results:
- A 25 mg/kg IV bolus of TXA in pediatric trauma patients approximates the Cmax of a 2g IV bolus in adults.
- No tested dose (20-35 mg/kg) achieved the adult AUC0-4h or AUC0-8h.
Conclusions:
- A 25 mg/kg IV TXA bolus is predicted to achieve similar peak drug concentration (Cmax) in children as in adults.
- Pediatric trauma patients may require more frequent TXA dosing for comparable total drug exposure.
Background:
Trauma is the most common cause of death in children >1 year of age, with hemorrhage being the most common preventable cause of death after injury. Antifibrinolytics like tranexamic acid (TXA) are a key aspect of trauma management in children, but optimal dosing remains unknown. The objective of this study was to derive a TXA dose in children with trauma-related bleeding that approximates the TXA exposure in adult trauma patients using a population pharmacokinetic (popPK) model from adults with severe traumatic injury.
Study Design And Methods:
Model-based simulation was performed by extrapolating a previously published popPK model of TXA in adults with trauma-related bleeding to pediatric patients. A virtual pediatric trauma population was simulated utilizing published covariate values and an allometrically scaled adult model applied to predict the TXA PK profile in children with trauma-related bleeding.
Results:
An IV TXA bolus of 25 mg/kg (max 2 g) in children with trauma-related bleeding approximates the Cmax after a 2 g IV bolus in an adult trauma population. No dose from 20 to 35 mg/kg achieved the AUC0-4h or AUC0-8h that results from a 2 g IV bolus in adults.
Discussion:
In children with trauma-related bleeding, a TXA 25 mg/kg IV bolus is predicted to approximate the Cmax achieved with a 2 g IV bolus in adults. More frequent dosing may be necessary in children to achieve a similar total drug exposure as adults with trauma-related bleeding.
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