Clinical Validation of a Volumetric Absorptive Micro-Sampling Device for Pharmacokinetic Studies With Tranexamic Acid

We assessed the accuracy of tranexamic acid (TXA) concentrations measured in capillary whole blood using volumetric absorptive micro-sampling (VAMS) devices. Paired venous and VAMS capillary blood samples were collected from 15 healthy volunteers participating in a pharmacokinetic study of alternati...

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Autores principales:	Stanislas Grassin-Delyle, Elodie Lamy, Michaela Semeraro, Iléana Runge, Jean-Marc Treluyer, Raoul Mansukhani, Monica Arribas, Ian Roberts, Haleema Shakur-Still
Formato:	article
Lenguaje:	EN
Publicado:	Frontiers Media S.A. 2021
Materias:	tranexamic acid volumetric absorptive micro-sampling pharmacokinetics whole blood capillary blood Therapeutics. Pharmacology RM1-950
Acceso en línea:	https://doaj.org/article/e72f452fe7b94b8c9d5be5c0957f2a55
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spelling	oai:doaj.org-article:e72f452fe7b94b8c9d5be5c0957f2a552021-11-30T12:52:34ZClinical Validation of a Volumetric Absorptive Micro-Sampling Device for Pharmacokinetic Studies With Tranexamic Acid1663-981210.3389/fphar.2021.764379https://doaj.org/article/e72f452fe7b94b8c9d5be5c0957f2a552021-11-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fphar.2021.764379/fullhttps://doaj.org/toc/1663-9812We assessed the accuracy of tranexamic acid (TXA) concentrations measured in capillary whole blood using volumetric absorptive micro-sampling (VAMS) devices. Paired venous and VAMS capillary blood samples were collected from 15 healthy volunteers participating in a pharmacokinetic study of alternative routes (oral, IM and IV) of administering TXA. To assess accuracy across a range of concentrations, blood was drawn at different times after TXA administration. We measured TXA concentrations in plasma, whole blood from samples collected by venepuncture and whole blood from venous and capillary samples collected using VAMS devices. TXA was measured using a validated high sensitivity liquid chromatography - mass spectrometry method. We used Bland-Altman plots to describe the agreement between the TXA concentrations obtained with the different methods. In the 42 matched samples, the mean plasma TXA concentration was 14.0 mg/L (range 2.6–36.5 mg/L) whereas the corresponding whole blood TXA concentration was 7.7 mg/L (range 1.6–17.5 mg/L). When comparing TXA concentrations in VAMS samples of venous and capillary whole blood, the average bias was 0.07 mg/L (lower and upper 95% limits of agreement: −2.1 and 2.2 mg/L respectively). When comparing TXA concentrations in venous whole blood and VAMS capillary whole blood, the average bias was 0.7 mg/L (limits of agreement: −2.7 and 4.0 mg/L). Volumetric absorptive micro-sampling devices are sufficiently accurate for use in pharmacokinetic studies of tranexamic acid treatment in the range of plasma concentrations relevant for the assessment of fibrinolysis inhibition.Stanislas Grassin-DelyleStanislas Grassin-DelyleElodie LamyMichaela SemeraroIléana RungeJean-Marc TreluyerJean-Marc TreluyerRaoul MansukhaniMonica ArribasIan RobertsHaleema Shakur-StillFrontiers Media S.A.articletranexamic acidvolumetric absorptive micro-samplingpharmacokineticswhole bloodcapillary bloodTherapeutics. PharmacologyRM1-950ENFrontiers in Pharmacology, Vol 12 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	tranexamic acid volumetric absorptive micro-sampling pharmacokinetics whole blood capillary blood Therapeutics. Pharmacology RM1-950
spellingShingle	tranexamic acid volumetric absorptive micro-sampling pharmacokinetics whole blood capillary blood Therapeutics. Pharmacology RM1-950 Stanislas Grassin-Delyle Stanislas Grassin-Delyle Elodie Lamy Michaela Semeraro Iléana Runge Jean-Marc Treluyer Jean-Marc Treluyer Raoul Mansukhani Monica Arribas Ian Roberts Haleema Shakur-Still Clinical Validation of a Volumetric Absorptive Micro-Sampling Device for Pharmacokinetic Studies With Tranexamic Acid
description	We assessed the accuracy of tranexamic acid (TXA) concentrations measured in capillary whole blood using volumetric absorptive micro-sampling (VAMS) devices. Paired venous and VAMS capillary blood samples were collected from 15 healthy volunteers participating in a pharmacokinetic study of alternative routes (oral, IM and IV) of administering TXA. To assess accuracy across a range of concentrations, blood was drawn at different times after TXA administration. We measured TXA concentrations in plasma, whole blood from samples collected by venepuncture and whole blood from venous and capillary samples collected using VAMS devices. TXA was measured using a validated high sensitivity liquid chromatography - mass spectrometry method. We used Bland-Altman plots to describe the agreement between the TXA concentrations obtained with the different methods. In the 42 matched samples, the mean plasma TXA concentration was 14.0 mg/L (range 2.6–36.5 mg/L) whereas the corresponding whole blood TXA concentration was 7.7 mg/L (range 1.6–17.5 mg/L). When comparing TXA concentrations in VAMS samples of venous and capillary whole blood, the average bias was 0.07 mg/L (lower and upper 95% limits of agreement: −2.1 and 2.2 mg/L respectively). When comparing TXA concentrations in venous whole blood and VAMS capillary whole blood, the average bias was 0.7 mg/L (limits of agreement: −2.7 and 4.0 mg/L). Volumetric absorptive micro-sampling devices are sufficiently accurate for use in pharmacokinetic studies of tranexamic acid treatment in the range of plasma concentrations relevant for the assessment of fibrinolysis inhibition.
format	article
author	Stanislas Grassin-Delyle Stanislas Grassin-Delyle Elodie Lamy Michaela Semeraro Iléana Runge Jean-Marc Treluyer Jean-Marc Treluyer Raoul Mansukhani Monica Arribas Ian Roberts Haleema Shakur-Still
author_facet	Stanislas Grassin-Delyle Stanislas Grassin-Delyle Elodie Lamy Michaela Semeraro Iléana Runge Jean-Marc Treluyer Jean-Marc Treluyer Raoul Mansukhani Monica Arribas Ian Roberts Haleema Shakur-Still
author_sort	Stanislas Grassin-Delyle
title	Clinical Validation of a Volumetric Absorptive Micro-Sampling Device for Pharmacokinetic Studies With Tranexamic Acid
title_short	Clinical Validation of a Volumetric Absorptive Micro-Sampling Device for Pharmacokinetic Studies With Tranexamic Acid
title_full	Clinical Validation of a Volumetric Absorptive Micro-Sampling Device for Pharmacokinetic Studies With Tranexamic Acid
title_fullStr	Clinical Validation of a Volumetric Absorptive Micro-Sampling Device for Pharmacokinetic Studies With Tranexamic Acid
title_full_unstemmed	Clinical Validation of a Volumetric Absorptive Micro-Sampling Device for Pharmacokinetic Studies With Tranexamic Acid
title_sort	clinical validation of a volumetric absorptive micro-sampling device for pharmacokinetic studies with tranexamic acid
publisher	Frontiers Media S.A.
publishDate	2021
url	https://doaj.org/article/e72f452fe7b94b8c9d5be5c0957f2a55
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Clinical Validation of a Volumetric Absorptive Micro-Sampling Device for Pharmacokinetic Studies With Tranexamic Acid

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