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Article Dans Une Revue Pharmaceutics Année : 2022

Pharmacokinetics of Curative Tranexamic Acid in Parturients Undergoing Cesarean Delivery

Résumé

The aim of this study was to evaluate the population pharmacokinetics of tranexamic acid (TXA) administered intravenously at a single dose of 0.5 or 1 g in parturients undergoing active hemorrhagic cesarean delivery and to evaluate the influence of patient variables on TXA pharmacokinetics. Subjects from three recruiting centers were included in this PK sub-study if randomized in the experimental group (i.v TXA 0.5 g or 1 g over one minute) of the TRACES study. Blood samples and two urinary samples were collected within 6 h after TXA injection. Parametric non-linear mixed-effect modeling (Monolix v2020R1) was computed. The final covariate model building used 315 blood and 117 urinary concentrations from seventy-nine patients. A two-compartment model with a double first-order elimination from the central compartment best described the data. The population estimates of clearance (CL), central volume of distribution (V1), and half-life for a typical 70 kg patient with an estimated renal clearance of 150 mL/min (Cockroft–Gault) were 0.14 L/h, 9.25 L, and 1.8 h. A correlation between estimated creatinine clearance and CL, body weight before pregnancy, and V1 was found and partly explained the PK variability. The final model was internally validated using a 500-run bootstrap. The first population pharmacokinetic model of TXA in active hemorrhagic caesarean section was successfully developed and internally validated. Keywords: caesarean section; intravenous; pharmacokinetics; postpartum hemo
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hal-04205777 , version 1 (28-02-2024)

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Sixtine Gilliot, Anne-Sophie Ducloy, Florence Loingeville, Benjamin Hennart, Delphine Allorge, et al.. Pharmacokinetics of Curative Tranexamic Acid in Parturients Undergoing Cesarean Delivery. Pharmaceutics, 2022, Pharmaceutics, 14 (3), pp.578. ⟨10.3390/pharmaceutics14030578⟩. ⟨hal-04205777⟩

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