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Pharmacokinetics of Curative Tranexamic Acid in Parturients Undergoing Cesarean Delivery

ULR-7365-Groupe de Recherche sur les Formes Injectables et les Technologies Associées (GRITA), Université de Lille, Centre Hospitalier Universitaire de Lille, F-59000 Lille, France. Institut de Pharmacie, Centre Hospitalier Universitaire de Lille, F-59000 Lille, France. Pôle Anesthésie-Réanimation, Hôpital Huriez, Centre Hospitalier Universitaire de Lille, F-59000 Lille, France. ULR2694-METRICS-Evaluation des Technologies de Santé et des Pratiques Médicales, Université de Lille, Centre Hospitalier Universitaire de Lille, F-59000 Lille, France. Unité Fonctionnelle de Toxicologie, Pôle Biologie Pathologie Génétique, Centre Biologie Pathologie, Centre Hospitalier Universitaire de Lille, F-59000 Lille, France. ULR 4483-IMPECS-IMPact de l'Environnement Chimique sur la Santé, Faculté de Médecine-Pôle Recherche, Université de Lille, 1 Place de Verdun, F-59045 Lille, France.

Pharmaceutics. 2022;14(3)
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Abstract
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.
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Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine