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Anticoagulant Effects of Dabigatran in Paediatric Patients Compared with Adults: Combined Data from Three Paediatric Clinical Trials.


ABSTRACT: BACKGROUND:?Physiological age-related changes in the haemostatic and coagulation systems result in differing anticoagulant assay responses to standard anticoagulants. Therefore, we investigated the response of anticoagulant assays to dabigatran etexilate (DE) in children compared with adults. OBJECTIVE:?This article assesses the relationship between plasma dabigatran concentration and coagulation assay results across age groups in children and adults. PATIENTS AND METHODS:?Data from three clinical trials in which children received DE following standard of care for venous thromboembolism were compared with data from adult clinical trials. The effects of dabigatran concentration on diluted thrombin time (dTT), ecarin clotting time (ECT) and activated partial thromboplastin time (aPTT) were analysed graphically and with modelling. RESULTS:?The concentration-dTT relationships were consistent in children across all ages and adults in the graphical analysis. For ECT and aPTT, relationships based on ratios over baseline were similar across all ages; absolute clotting times showed that the same exposure resulted in longer clotting times in some of the children aged?

SUBMITTER: Maas H 

PROVIDER: S-EPMC6202931 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Anticoagulant Effects of Dabigatran in Paediatric Patients Compared with Adults: Combined Data from Three Paediatric Clinical Trials.

Maas Hugo H   Gropper Savion S   Huang Fenglei F   Stangier Joachim J   Tartakovsky Igor I   Brueckmann Martina M   Halton Jacqueline M L JML   Mitchell Lesley G LG  

Thrombosis and haemostasis 20180815 9


<h4>Background</h4> Physiological age-related changes in the haemostatic and coagulation systems result in differing anticoagulant assay responses to standard anticoagulants. Therefore, we investigated the response of anticoagulant assays to dabigatran etexilate (DE) in children compared with adults.<h4>Objective</h4> This article assesses the relationship between plasma dabigatran concentration and coagulation assay results across age groups in children and adults.<h4>Patients and methods</h4>   ...[more]

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