Thromb Haemost 2020; 120(07): 1116-1127
DOI: 10.1055/s-0040-1712956
New Technologies, Diagnostic Tools and Drugs
Georg Thieme Verlag KG Stuttgart · New York

Comprehensive Blood Coagulation Profiling in Patients Using iCoagLab: Comparison Against Thromboelastography

Markandey M. Tripathi*
1  Wellman Center for Photomedicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, United States
,
Diane M. Tshikudi*
1  Wellman Center for Photomedicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, United States
,
Zeinab Hajjarian
1  Wellman Center for Photomedicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, United States
,
Dallas C. Hack
2  Department of Neurosurgery, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, United States
,
Elizabeth M. Van Cott
3  Department of Pathology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, United States
,
Seemantini K. Nadkarni
1  Wellman Center for Photomedicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, United States
› Author Affiliations
Funding The following funding sources supported this work: National Institutes of Health-RO1 HL142272 (to S.K.N), R21 EB023012 (to S.K.N), RO1 HL119867 (to S.K.N) and the Department of Defense-AFOSR FA 9550-11-1-0331 (to S.K.N).
Further Information

Publication History

22 November 2019

23 April 2020

Publication Date:
22 June 2020 (online)

Abstract

Delayed identification of coagulopathy and bleeding increases the risk of organ failure and death in hospitalized patients. Timely and accurate identification of impaired coagulation at the point-of-care can proactively identify bleeding risk and guide resuscitation, resulting in improved outcomes for patients. We test the accuracy of a novel optical coagulation sensing approach, termed iCoagLab, for comprehensive whole blood coagulation profiling and investigate its diagnostic accuracy in identifying patients at elevated bleeding risk. Whole blood samples from patients (N = 270) undergoing conventional coagulation testing were measured using the iCoagLab device. Recalcified and kaolin-activated blood samples were loaded in disposable cartridges and time-varying intensity fluctuation of laser speckle patterns were measured to quantify the clot viscoelastic modulus during coagulation. Coagulation parameters including the reaction time (R), clot progression time (K), clot progression rate (α), and maximum clot strength (MA) were derived from clot viscoelasticity traces and compared with mechanical thromboelastography (TEG). In all patients, a good correlation between iCoagLab- and TEG-derived parameters was observed (p < 0.001). Multivariate analysis showed that iCoagLab-derived parameters identified bleeding risk with sensitivity (94%) identical to, and diagnostic accuracy (89%) higher than TEG (87%). The diagnostic specificity of iCoagLab (77%) was significantly higher than TEG (69%). By rapidly and comprehensively permitting blood coagulation profiling the iCoagLab innovation is likely to advance the capability to identify patients with elevated risk for bleeding, with the ultimate goal of preventing life-threatening hemorrhage.

Authors' Contributions

This study was a team effort among all the authors. S.K.N. conceived the iCoagLab technology and developed the proof-of-concept iCoagLab device. M.M.T. and S.K.N developed the iCoagLab instrument used in this study. M.M.T. and D.M.T. conducted the experiments. M.M.T, S.K.N., and Z.H. developed the iCoagLab processing algorithms. M.M.T. and S.K.N. analyzed the data. S.K.N., M.M.T., and D.M.T. wrote the manuscript. E.M.V.C. and D.C.H. provided guidance on interpretation of the iCoagLab data. All authors have read the journal's authorship agreement and have reviewed and approved the manuscript.


* Equal contribution.


Supplementary Material