Title :

Pharmacokinetics of Curative Tranexamic Acid in Parturients Undergoing Cesarean Delivery

Author(s) :

Gilliot, Sixtine [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - ULR 7365
Ducloy, Anne-Sophie [Auteur]
495476|||Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA] (VALID)
300097|||Hôpital Claude Huriez [Lille] (VALID)
Loingeville, Florence [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Hennart, Benjamin [Auteur]
IMPact de l'Environnement Chimique sur la Santé humaine (IMPECS) - ULR 4483
Allorge, Delphine [Auteur]
IMPact de l'Environnement Chimique sur la Santé humaine (IMPECS) - ULR 4483
Lebuffe, Gilles [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - ULR 7365
Odou, Pascal [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - ULR 7365

Journal title :

Pharmaceutics

Volume number :

14

Pages :

578

Publisher :

MDPI

Publication date :

2022-03-27

ISSN :

1999-4923

English keyword(s) :

tranexamic acid
postpartum hemorrhage
pharmacokinetics
intravenous
caesarean section

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

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 ...
Show more >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 hemoShow less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Other project(s) or funding source(s) :

Ministry of Health (PHRC n◦ 14-0032)
grants allocated for pharmacobiological analysis and modelling by the National Agency for Drugs Security (ANSM AAP 15-003)

Administrative institution(s) :

Université de Lille
CHU Lille

Collections :

• Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - ULR 7365
• IMPact de l'Environnement Chimique sur la Santé humaine (IMPECS) - ULR 4483

Submission date :

2023-05-25T02:43:15Z
2023-09-13T08:29:47Z
2024-02-28T16:28:29Z