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

Research output: Contribution to journalResearch articleContributedpeer-review



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.


Original languageEnglish
Pages (from-to)1954-1962
Number of pages9
JournalThrombosis and haemostasis
Issue number11
Publication statusPublished - Nov 2022

External IDs

PubMed 35672013
Scopus 85137556856
ORCID /0000-0001-7049-186X/work/142239910
ORCID /0000-0003-3953-3253/work/142251746
ORCID /0000-0001-8494-1403/work/145699006
PubMedCentral PMC9626030



  • Humans, Tissue Plasminogen Activator, Thrombolytic Therapy/adverse effects, Ischemic Stroke, Prospective Studies, Point-of-Care Systems, Stroke/diagnosis, Anticoagulants/therapeutic use, Brain Ischemia/diagnosis, Treatment Outcome, Observational Studies as Topic