Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Grassin-Delyle, Stanislas, Lamy, Elodie, Semeraro, Michaela, Runge, Iléana, Treluyer, Jean-Marc, Mansukhani, Raoul, Arribas, Monica, Roberts, Ian, Shakur-Still, Haleema
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8650113/
https://www.ncbi.nlm.nih.gov/pubmed/34887763
http://dx.doi.org/10.3389/fphar.2021.764379
_version_ 1784611140048781312
author Grassin-Delyle, Stanislas
Lamy, Elodie
Semeraro, Michaela
Runge, Iléana
Treluyer, Jean-Marc
Mansukhani, Raoul
Arribas, Monica
Roberts, Ian
Shakur-Still, Haleema
author_facet Grassin-Delyle, Stanislas
Lamy, Elodie
Semeraro, Michaela
Runge, Iléana
Treluyer, Jean-Marc
Mansukhani, Raoul
Arribas, Monica
Roberts, Ian
Shakur-Still, Haleema
author_sort Grassin-Delyle, Stanislas
collection PubMed
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 Online
Article
Text
id pubmed-8650113
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher Frontiers Media S.A.
record_format MEDLINE/PubMed
spelling pubmed-86501132021-12-08 Clinical Validation of a Volumetric Absorptive Micro-Sampling Device for Pharmacokinetic Studies With Tranexamic Acid Grassin-Delyle, Stanislas Lamy, Elodie Semeraro, Michaela Runge, Iléana Treluyer, Jean-Marc Mansukhani, Raoul Arribas, Monica Roberts, Ian Shakur-Still, Haleema Front Pharmacol Pharmacology 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. Frontiers Media S.A. 2021-11-23 /pmc/articles/PMC8650113/ /pubmed/34887763 http://dx.doi.org/10.3389/fphar.2021.764379 Text en Copyright © 2021 Grassin-Delyle, Lamy, Semeraro, Runge, Treluyer, Mansukhani, Arribas, Roberts and Shakur-Still. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pharmacology
Grassin-Delyle, Stanislas
Lamy, Elodie
Semeraro, Michaela
Runge, Iléana
Treluyer, Jean-Marc
Mansukhani, Raoul
Arribas, Monica
Roberts, Ian
Shakur-Still, Haleema
Clinical Validation of a Volumetric Absorptive Micro-Sampling Device for Pharmacokinetic Studies With Tranexamic Acid
title 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_short 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
topic Pharmacology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8650113/
https://www.ncbi.nlm.nih.gov/pubmed/34887763
http://dx.doi.org/10.3389/fphar.2021.764379
work_keys_str_mv AT grassindelylestanislas clinicalvalidationofavolumetricabsorptivemicrosamplingdeviceforpharmacokineticstudieswithtranexamicacid
AT lamyelodie clinicalvalidationofavolumetricabsorptivemicrosamplingdeviceforpharmacokineticstudieswithtranexamicacid
AT semeraromichaela clinicalvalidationofavolumetricabsorptivemicrosamplingdeviceforpharmacokineticstudieswithtranexamicacid
AT rungeileana clinicalvalidationofavolumetricabsorptivemicrosamplingdeviceforpharmacokineticstudieswithtranexamicacid
AT treluyerjeanmarc clinicalvalidationofavolumetricabsorptivemicrosamplingdeviceforpharmacokineticstudieswithtranexamicacid
AT mansukhaniraoul clinicalvalidationofavolumetricabsorptivemicrosamplingdeviceforpharmacokineticstudieswithtranexamicacid
AT arribasmonica clinicalvalidationofavolumetricabsorptivemicrosamplingdeviceforpharmacokineticstudieswithtranexamicacid
AT robertsian clinicalvalidationofavolumetricabsorptivemicrosamplingdeviceforpharmacokineticstudieswithtranexamicacid
AT shakurstillhaleema clinicalvalidationofavolumetricabsorptivemicrosamplingdeviceforpharmacokineticstudieswithtranexamicacid