Urine-based point-of-care testing for factor-Xa-inhibitors in acute ischemic stroke patients: a feasibility study

Thorsten R Doeppner; Linus Olbricht; Toska Maxhuni; Omar Alhaj Omar; Ulrich J Sachs; Martin B Juenemann; Hagen B Huttner; Stefan T Gerner

doi:10.3389/fneur.2023.1330421

Urine-based point-of-care testing for factor-Xa-inhibitors in acute ischemic stroke patients: a feasibility study

Front Neurol. 2023 Dec 15:14:1330421. doi: 10.3389/fneur.2023.1330421. eCollection 2023.

Authors

Thorsten R Doeppner^#^{1

2

3

4}, Linus Olbricht^#¹, Toska Maxhuni¹, Omar Alhaj Omar¹, Ulrich J Sachs⁵, Martin B Juenemann¹, Hagen B Huttner^{1

2

3}, Stefan T Gerner^{1

2

3}

Affiliations

¹ Department of Neurology, University Hospital Giessen, Giessen, Germany.
² Center for Mind, Brain and Behavior (CMBB), Philipps University Marburg and Justus Liebig University Giessen, Giessen, Germany.
³ Translational Neuroscience Network Giessen, Justus Liebig University Giessen, Giessen, Germany.
⁴ Department of Neurology, University of Göttingen, Göttingen, Germany.
⁵ Division of Haemostaseology, University Hospital Giessen, Giessen, Germany.

^# Contributed equally.

Abstract

Introduction: Direct oral anticoagulants (DOACs) have become widely used in clinical practice for preventing thromboembolic events. Point-of-care testing methods, particularly those based on urine samples, offer a promising approach for rapid and accurate assessment of DOAC presence. This pilot study aims to evaluate the utility of a urine-based DOAC dipstick test as a point-of-care tool for identifying DOAB presence in acute ischemic stroke (AIS) or transient ischemic attack (TIA) patients.

Patients and methods: This prospective pilot study included patients with AIS/TIA eligible for DOAC-measurement. After exclusion of 3 patients, 23 patients with DOAC-intake (DOAC group; factor-Xa-inhibitors; n = 23) and 21 patients without DOAC-intake (control-group) remained for analyses. The urine-based DOAC dipstick test and parallel blood-based specific DOAC-level assessment were performed in all patients. Time-intervals of sampling urine/blood sampling and result of DOAC-test were recorded to analyze a potential time benefit based on dipstick evaluation.

Results: The urine-based DOAC dipstick test demonstrated high sensitivity (100%) and specificity (100%), correctly identifying all patients with anticoagulatory activity due to DOAC intake (i.e., anti-Xalevel ≥30 ng/mL). Moreover, the visual readout of the test provided semiquantitative information on drug-specific anti-Xa levels, showing a sensitivity of 83% and specificity of 93% to detect anti-Xa levels ≥120 ng/mL. The dipstick test exhibited a median time-benefit of 2:25 h compared to standard blood-based DOAC-level testing.

Discussion: The results of this pilot study underline the efficacy of urine-based point-of-care testing as a rapid and reliable method for assessing DOAC presence in patients with acute ischemic stroke.

Conclusion: The value of this tool for clinical decision-making in stroke management needs to be established in future trials.Clinical Trial Registration: Clinicaltrails.org identifier [NCT06037200].

Keywords: anticoagulation; direct oral anticoagulant; factor-Xa-inhibitor; ischemic stroke; point-of-care test.

Associated data

ClinicalTrials.gov/NCT06037200

Grants and funding

DOASENSE dipsticks and the reader were provided by the company Doasense^TM. It should be emphasized that Doasense^TM had no involvement in the design, conduct, or analysis of this study.