Annahita Sedghi1, Lars Heubner2, Anna Klimova3,4, Oliver Tiebel5, Jörg Pietsch6, Martin Mirus2, Kristian Barlinn1, Tabea Minx1, Jan Beyer-Westendorf7, Volker Puetz1, Peter Spieth2, Timo Siepmann1. 1. Department of Neurology, Dresden Neurovascular Center, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany. 2. Department of Anesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus, Dresden, Germany. 3. National Center for Tumor Diseases Partner Site Dresden, University Hospital Carl Gustav Carus, Dresden, Germany. 4. Institute for Medical Informatics and Biometry, Carl Gustav Carus Faculty of Medicine, Technische Universität Dresden, Dresden, Germany. 5. Institute of Clinical Chemistry, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany. 6. Institute of Forensic Medicine, Carl Gustav Carus Faculty of Medicine, Technische Universität Dresden, Dresden, Germany. 7. Department of Internal Medicine, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
Abstract
BACKGROUND: Treatment of ischemic stroke with recombinant tissue plasminogen activator for intravenous thrombolysis (IVT) must be delivered within a narrow time window after symptom onset. This effective hyperacute treatment can be administered after ruling out active anticoagulation with direct oral anticoagulants (DOACs). Whenever this is impractical, e.g., due to aphasia, plasmatic DOAC levels are measured with a consequent delay in the IVT decision-making process ranging from 30 to 60 minutes of time. This study will test the hypothesis that hyperacute point-of-care assessment of clotting time in the patient's whole blood has sufficient diagnostic accuracy to determine immediately whether stroke patients are pretreated with DOAC. METHODS AND DESIGN: This will be a prospective single-center diagnostic accuracy study in 1,850 consecutive acute ischemic stroke patients at a tertiary stroke center in Saxony, Germany. Presence of active anticoagulation with DOAC will be determined by point-of-care quantification of clotting time via whole blood viscoelastic testing (ClotPro) using Russell venom viper and ecarin assay compared with high-performance liquid chromatography-tandem mass spectrometry as the reference standard. DISCUSSION: Viscoelastic point-of-care assessment of clotting time in whole blood might improve swift delivery of time-sensitive hyperacute treatment with IVT in stroke patients. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).
BACKGROUND: Treatment of ischemic stroke with recombinant tissue plasminogen activator for intravenous thrombolysis (IVT) must be delivered within a narrow time window after symptom onset. This effective hyperacute treatment can be administered after ruling out active anticoagulation with direct oral anticoagulants (DOACs). Whenever this is impractical, e.g., due to aphasia, plasmatic DOAC levels are measured with a consequent delay in the IVT decision-making process ranging from 30 to 60 minutes of time. This study will test the hypothesis that hyperacute point-of-care assessment of clotting time in the patient's whole blood has sufficient diagnostic accuracy to determine immediately whether stroke patients are pretreated with DOAC. METHODS AND DESIGN: This will be a prospective single-center diagnostic accuracy study in 1,850 consecutive acute ischemic stroke patients at a tertiary stroke center in Saxony, Germany. Presence of active anticoagulation with DOAC will be determined by point-of-care quantification of clotting time via whole blood viscoelastic testing (ClotPro) using Russell venom viper and ecarin assay compared with high-performance liquid chromatography-tandem mass spectrometry as the reference standard. DISCUSSION: Viscoelastic point-of-care assessment of clotting time in whole blood might improve swift delivery of time-sensitive hyperacute treatment with IVT in stroke patients. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).
Authors: Tom A Schröder; Henry Leonhardt; Dominik Haim; Christian Bräuer; Kiriaki K Papadopoulos; Oliver Vicent; Andreas Güldner; Martin Mirus; Jürgen Schmidt; Hanns C Held; Oliver Tiebel; Thomas Birkner; Jan Beyer-Westendorf; Günter Lauer; Peter M Spieth; Thea Koch; Lars Heubner Journal: J Pers Med Date: 2022-07-27