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

Area of Science:

• Biomedical Engineering
• Clinical Diagnostics
• Hematology

Background:

• Delayed identification of coagulopathy increases organ failure and mortality risk in hospitalized patients.
• Accurate point-of-care coagulation assessment is crucial for proactive bleeding risk identification and guiding resuscitation.

Purpose of the Study:

• To evaluate the accuracy of a novel optical coagulation sensing approach, iCoagLab, for comprehensive whole blood profiling.
• To investigate iCoagLab's diagnostic accuracy in identifying patients with elevated bleeding risk.

Main Methods:

• Whole blood samples (N=270) were analyzed using iCoagLab and compared to mechanical thromboelastography (TEG).
• iCoagLab measured time-varying laser speckle patterns to quantify clot viscoelastic modulus.
• Coagulation parameters (R, K, α, MA) were derived and correlated between methods.

Main Results:

• A strong correlation was found between iCoagLab and TEG parameters (p < 0.001).
• iCoagLab demonstrated higher diagnostic accuracy (89%) and specificity (77%) for bleeding risk compared to TEG (87% and 69%).
• iCoagLab achieved sensitivity (94%) identical to TEG.

Conclusions:

• iCoagLab provides rapid and comprehensive blood coagulation profiling.
• This novel optical sensing approach significantly advances the identification of patients at elevated bleeding risk.
• Early identification of bleeding risk can prevent life-threatening hemorrhage and improve patient outcomes.