CC BY-NC-ND 4.0 · Thromb Haemost 2022; 122(11): 1954-1962
DOI: 10.1055/a-1869-7853
Trial Protocol Design Paper

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

Annahita Sedghi*
1   Department of Neurology, Dresden Neurovascular Center, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany
,
Lars Heubner*
2   Department of Anesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus, Dresden, Germany
,
Anna Klimova
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
,
Oliver Tiebel
5   Institute of Clinical Chemistry, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany
,
Jörg Pietsch
6   Institute of Forensic Medicine, Carl Gustav Carus Faculty of Medicine, Technische Universität Dresden, Dresden, Germany
,
Martin Mirus
2   Department of Anesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus, Dresden, Germany
,
Kristian Barlinn
1   Department of Neurology, Dresden Neurovascular Center, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany
,
Tabea Minx
1   Department of Neurology, Dresden Neurovascular Center, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany
,
Jan Beyer-Westendorf
7   Department of Internal Medicine, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany
,
Volker Puetz
1   Department of Neurology, Dresden Neurovascular Center, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany
,
Peter Spieth**
2   Department of Anesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus, Dresden, Germany
,
Timo Siepmann**
1   Department of Neurology, Dresden Neurovascular Center, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany
› Author Affiliations
Funding The study was funded by the Faculty of Medicine Carl Gustav Carus of the Technische Universität Dresden as well as the University Hospital Carl Gustav Carus Dresden.

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.

Author Contributions

A.S., L.H., O.T., J.P., J.B.-W., V.P., P.S., and T.S. conceptualized the study. A.K. and A.S. were involved in sample size calculation and statistical analysis. A.S. wrote the first draft of the manuscript. O.T., J.P., J.B.-W., P.S., and T.S. provided resources. L.H., A.K., O.T., J.P., M.M., K.B., T.M., J.B.-W., V.P., P.S., and T.S. reviewed the manuscript for intellectual content. All authors agreed to be accountable for the content of the work.


Ethical Approval

The study has been conducted according to the current revised form of the Helsinki Declaration (2000, Edinburgh, Scotland). The study protocol has been approved by the institutional review board (IRB) of Technische Universität Dresden (Study reference: BO-EK 515102021). This study is registered with the German Clinical Trials Register DRKS00028597.


Informed Consent

No written informed consent is necessary as all screening or specific quantitative laboratory assays are performed as part of clinical routine. Thereby, a prospective database is generated. The index test as well as the reference test is intended to measure the same parameters but with a different method and diagnostic accuracy.


Confidentiality

Physical copies of informed consent forms will be stored onsite and converted to electronic files. Case report forms will not contain patients' initials or birth dates but only a study number. All the data will be treated confidentially and only trial investigators will be authorized to access to the hard drives.


Access to Data

The final trial dataset will be available to all investigators of the study.


Dissemination Policy

This protocol paper was written in accordance with the SPIRIT 2013 Statement on the composition of protocol papers (https://www.spirit-statement.org/protocol-version/). The complete dataset and statistical code will be available upon reasonable request.


* Shared first authorship.


** Shared last authorship.




Publication History

Received: 02 April 2022

Accepted: 27 May 2022

Accepted Manuscript online:
07 June 2022

Article published online:
17 October 2022

© 2022. 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/)

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