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Monitoring DOACs with a Novel Dielectric Microsensor: A Clinical Study.

Authors
  • Maji, Debnath1
  • Opneja, Aman2, 3
  • Suster, Michael A1
  • Bane, Kara L3
  • Wilson, Brigid M4, 5
  • Mohseni, Pedram1
  • Stavrou, Evi X3, 6
  • 1 Department of Electrical, Computer, and Systems Engineering, Case Western Reserve University, Cleveland, Ohio, United States. , (United States)
  • 2 Hematology and Oncology Division, Department of Medicine, University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States. , (United States)
  • 3 Division of Hematology-Oncology, Department of Medicine, Case Western Reserve University School of Medicine, Cleveland, Ohio, United States. , (United States)
  • 4 Geriatric Research Education and Clinical Center, Louis Stokes Cleveland Veterans Administration Medical Center, VA Northeast Ohio Healthcare System, Cleveland, Ohio, United States. , (United States)
  • 5 Division of Infectious Diseases and HIV Medicine, Department of Medicine, Case Western Reserve University School of Medicine, Cleveland, Ohio, United States. , (United States)
  • 6 Section of Hematology-Oncology, Department of Medicine, Louis Stokes Cleveland Veterans Administration Medical Center, VA Northeast Ohio Healthcare System, Cleveland, Ohio, United States. , (United States)
Type
Published Article
Journal
Thrombosis and Haemostasis
Publisher
Georg Thieme Verlag KG
Publication Date
Jan 01, 2021
Volume
121
Issue
1
Pages
58–69
Identifiers
DOI: 10.1055/s-0040-1715589
PMID: 32877954
Source
Medline
Language
English
License
Unknown

Abstract

There are acute settings where assessing the anticoagulant effect of direct oral anticoagulants (DOACs) can be useful. Due to variability among routine coagulation tests, there is an unmet need for an assay that detects DOAC effects within minutes in the laboratory or at the point of care. We developed a novel dielectric microsensor, termed ClotChip, and previously showed that the time to reach peak permittivity (T peak) is a sensitive parameter of coagulation function. We conducted a prospective, single-center, pilot study to determine its clinical utility at detecting DOAC anticoagulant effects in whole blood. We accrued 154 individuals: 50 healthy volunteers, 49 rivaroxaban patients, 47 apixaban, and 8 dabigatran patients. Blood samples underwent ClotChip measurements and plasma coagulation tests. Control mean T peak was 428 seconds (95% confidence interval [CI]: 401-455 seconds). For rivaroxaban, mean T peak was 592 seconds (95% CI: 550-634 seconds). A receiver operating characteristic curve showed that the area under the curve (AUC) predicting rivaroxaban using T peak was 0.83 (95% CI: 0.75-0.91, p < 0.01). For apixaban, mean T peak was 594 seconds (95% CI: 548-639 seconds); AUC was 0.82 (95% CI: 0.73-0.91, p < 0.01). For dabigatran, mean T peak was 894 seconds (95% CI: 701-1,086 seconds); AUC was 1 (p < 0.01). Specificity for all DOACs was 88%; sensitivity ranged from 72 to 100%. This diagnostic study using samples from "real-world" DOAC patients supports that ClotChip exhibits high sensitivity at detecting DOAC anticoagulant effects in a disposable portable platform, using a miniscule amount of whole blood (<10 µL). Thieme. All rights reserved.

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