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. 2022 Nov;122(11):1954-1962.
doi: 10.1055/a-1869-7853. Epub 2022 Jun 7.

Point-of-Care Assessment of Direct Oral Anticoagulation in Acute Ischemic Stroke: Protocol for a Prospective Observational Diagnostic Accuracy Study

Annahita Sedghi  1 , Lars Heubner  2 , Anna Klimova  3   4 , Oliver Tiebel  5 , Jörg Pietsch  6 , Martin Mirus  2 , Kristian Barlinn  1 , Tabea Minx  1 , Jan Beyer-Westendorf  7 , Volker Puetz  1 , Peter Spieth  2 , Timo Siepmann  1
Affiliations

Point-of-Care Assessment of Direct Oral Anticoagulation in Acute Ischemic Stroke: Protocol for a Prospective Observational Diagnostic Accuracy Study

Annahita Sedghi et al. Thromb Haemost. 2022 Nov.

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.

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Conflict of interest statement

T.S. received grants from the German Federal Ministry of Health and Kurt Goldstein Institut, royalties from Astra-zeneca for consulting and from Dresden International University for serving as a program director and a lecturer of the Master's Program in Clinical Research. None of these activities were related to the current study. The other authors report no conflict of interest.

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