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Pharmaceutics
Volume 14
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10.3390/pharmaceutics14030578
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Article

Pharmacokinetics of Curative Tranexamic Acid in Parturients Undergoing Cesarean Delivery

by
Sixtine Gilliot
1,2,*,
Anne-Sophie Ducloy-Bouthors
1,3,
Florence Loingeville
4,
Benjamin Hennart
5,
Delphine Allorge
5,6,
Gilles Lebuffe
1,3 and
Pascal Odou
1,2
1
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
2
Institut de Pharmacie, Centre Hospitalier Universitaire de Lille, F-59000 Lille, France
3
Pôle Anesthésie-Réanimation, Hôpital Huriez, Centre Hospitalier Universitaire de Lille, F-59000 Lille, France
4
ULR2694—METRICS—Evaluation des Technologies de Santé et des Pratiques Médicales, Université de Lille, Centre Hospitalier Universitaire de Lille, F-59000 Lille, France
5
Unité Fonctionnelle de Toxicologie, Pôle Biologie Pathologie Génétique, Centre Biologie Pathologie, Centre Hospitalier Universitaire de Lille, F-59000 Lille, France
6
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
*
Author to whom correspondence should be addressed.
Pharmaceutics 2022, 14(3), 578; https://doi.org/10.3390/pharmaceutics14030578
Submission received: 28 January 2022 / Revised: 27 February 2022 / Accepted: 2 March 2022 / Published: 6 March 2022
(This article belongs to the Special Issue The Role of Pharmacometrics in Drug Discovery and Development Process (Volume II))
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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.
Keywords: caesarean section; intravenous; pharmacokinetics; postpartum hemorrhage; tranexamic acid caesarean section; intravenous; pharmacokinetics; postpartum hemorrhage; tranexamic acid

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MDPI and ACS Style

Gilliot, S.; Ducloy-Bouthors, A.-S.; Loingeville, F.; Hennart, B.; Allorge, D.; Lebuffe, G.; Odou, P. Pharmacokinetics of Curative Tranexamic Acid in Parturients Undergoing Cesarean Delivery. Pharmaceutics 2022, 14, 578. https://doi.org/10.3390/pharmaceutics14030578

AMA Style

Gilliot S, Ducloy-Bouthors A-S, Loingeville F, Hennart B, Allorge D, Lebuffe G, Odou P. Pharmacokinetics of Curative Tranexamic Acid in Parturients Undergoing Cesarean Delivery. Pharmaceutics. 2022; 14(3):578. https://doi.org/10.3390/pharmaceutics14030578

Chicago/Turabian Style

Gilliot, Sixtine, Anne-Sophie Ducloy-Bouthors, Florence Loingeville, Benjamin Hennart, Delphine Allorge, Gilles Lebuffe, and Pascal Odou. 2022. "Pharmacokinetics of Curative Tranexamic Acid in Parturients Undergoing Cesarean Delivery" Pharmaceutics 14, no. 3: 578. https://doi.org/10.3390/pharmaceutics14030578

APA Style

Gilliot, S., Ducloy-Bouthors, A.-S., Loingeville, F., Hennart, B., Allorge, D., Lebuffe, G., & Odou, P. (2022). Pharmacokinetics of Curative Tranexamic Acid in Parturients Undergoing Cesarean Delivery. Pharmaceutics, 14(3), 578. https://doi.org/10.3390/pharmaceutics14030578

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