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• W2894978654 abstract "Essentials•A rapid test to detect thrombin inhibition by dabigatran would be valuable in acute situations.•A thrombin‐based trigger was applied in whole blood using rotation thromboelastometry.•Effects of dabigatran were assessed in vitro and in samples from patients on dabigatran.•The test produced data rapidly and was sensitive to dabigatran concentrations from 20 to 500 ng mL−1.AcknowledgementsThe authors are grateful to K. Aguilera and L. Gabrielsson for their skillful care of the study population. The study was supported by a collaborative research agreement between Boehringer Ingelheim and Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital (H. Wallén), by a grant from CSL Behring to Transfusion Medicine, Karolinska University Hospital (A. Wikman), and by grants from the Swedish Heart‐Lung Foundation (M. Skeppholm), the Stockholm County Council (ALF project; M. Skeppholm) and the Swedish Society of Medicine (A. Ågren).Boehringer IngelheimCSL BehringSwedish Heart‐Lung FoundationStockholm County CouncilSwedish Society of MedicineSummary: BackgroundRapid determination of the anticoagulant effect of dabigatran is essential in emergency situations.ObjectiveTo study a viscoelastic test (rotational thromboelastometry [ROTEM]) for rapid determination of dabigatran effects in whole blood samples.MethodROTEM measurements were performed with comparison of two triggers (thrombin‐based versus the commercial tissue factor‐based trigger Ex‐tem) in samples from 10 healthy donors spiked with dabigatran (20–500 ng mL−1) and in samples from 35 patients receiving dabigatran treatment; 10 healthy subjects served as controls. Clotting time (CT) and the difference in CT without versus with addition of the dabigatran antidote idarucizumab (CTdiff) were measured. Addition of idarucizumab reveals the contribution of dabigatran to ROTEM measurements and its potential reversibility.ResultsIn vitro studies showed that thrombin CT and thrombin CTdiff were more sensitive than Ex‐tem CT and Ex‐tem CTdiff in detecting dabigatran in whole blood samples. In patient samples, when thrombin CT and thrombin CTdiff were used, it was possible to detect dabigatran with a cut‐off of dabigatran at 20 ng mL−1, whereas, when Ex‐tem CT and Ex‐tem CTdiff were used, the method was less sensitive. Data from patient samples were obtained within 15 min of blood sampling.ConclusionsROTEM CT with a thrombin‐based trigger is more sensitive to dabigatran effects than Ex‐tem CT, and detects anticoagulant effects of drug concentrations in the low–very low therapeutic range. Analysis with idarucizumab (CTdiff) reveals dabigatran‐specific effects. As data are rapidly obtained, this method could, with further development and validation of its performance, be suitable for detecting clinically significant dabigatran effects in emergency situations. Essentials•A rapid test to detect thrombin inhibition by dabigatran would be valuable in acute situations.•A thrombin‐based trigger was applied in whole blood using rotation thromboelastometry.•Effects of dabigatran were assessed in vitro and in samples from patients on dabigatran.•The test produced data rapidly and was sensitive to dabigatran concentrations from 20 to 500 ng mL−1.AcknowledgementsThe authors are grateful to K. Aguilera and L. Gabrielsson for their skillful care of the study population. The study was supported by a collaborative research agreement between Boehringer Ingelheim and Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital (H. Wallén), by a grant from CSL Behring to Transfusion Medicine, Karolinska University Hospital (A. Wikman), and by grants from the Swedish Heart‐Lung Foundation (M. Skeppholm), the Stockholm County Council (ALF project; M. Skeppholm) and the Swedish Society of Medicine (A. Ågren).Boehringer IngelheimCSL BehringSwedish Heart‐Lung FoundationStockholm County CouncilSwedish Society of Medicine •A rapid test to detect thrombin inhibition by dabigatran would be valuable in acute situations.•A thrombin‐based trigger was applied in whole blood using rotation thromboelastometry.•Effects of dabigatran were assessed in vitro and in samples from patients on dabigatran.•The test produced data rapidly and was sensitive to dabigatran concentrations from 20 to 500 ng mL−1. The authors are grateful to K. Aguilera and L. Gabrielsson for their skillful care of the study population. The study was supported by a collaborative research agreement between Boehringer Ingelheim and Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital (H. Wallén), by a grant from CSL Behring to Transfusion Medicine, Karolinska University Hospital (A. Wikman), and by grants from the Swedish Heart‐Lung Foundation (M. Skeppholm), the Stockholm County Council (ALF project; M. Skeppholm) and the Swedish Society of Medicine (A. Ågren).Boehringer IngelheimCSL BehringSwedish Heart‐Lung FoundationStockholm County CouncilSwedish Society of Medicine Rapid determination of the anticoagulant effect of dabigatran is essential in emergency situations. To study a viscoelastic test (rotational thromboelastometry [ROTEM]) for rapid determination of dabigatran effects in whole blood samples. ROTEM measurements were performed with comparison of two triggers (thrombin‐based versus the commercial tissue factor‐based trigger Ex‐tem) in samples from 10 healthy donors spiked with dabigatran (20–500 ng mL−1) and in samples from 35 patients receiving dabigatran treatment; 10 healthy subjects served as controls. Clotting time (CT) and the difference in CT without versus with addition of the dabigatran antidote idarucizumab (CTdiff) were measured. Addition of idarucizumab reveals the contribution of dabigatran to ROTEM measurements and its potential reversibility. In vitro studies showed that thrombin CT and thrombin CTdiff were more sensitive than Ex‐tem CT and Ex‐tem CTdiff in detecting dabigatran in whole blood samples. In patient samples, when thrombin CT and thrombin CTdiff were used, it was possible to detect dabigatran with a cut‐off of dabigatran at 20 ng mL−1, whereas, when Ex‐tem CT and Ex‐tem CTdiff were used, the method was less sensitive. Data from patient samples were obtained within 15 min of blood sampling. ROTEM CT with a thrombin‐based trigger is more sensitive to dabigatran effects than Ex‐tem CT, and detects anticoagulant effects of drug concentrations in the low–very low therapeutic range. Analysis with idarucizumab (CTdiff) reveals dabigatran‐specific effects. As data are rapidly obtained, this method could, with further development and validation of its performance, be suitable for detecting clinically significant dabigatran effects in emergency situations." @default.
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• W2894978654 date "2018-12-01" @default.
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• W2894978654 title "Rapid determination of anticoagulating effects of dabigatran in whole blood with rotational thromboelastometry and a thrombin‐based trigger" @default.
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