Comparison of QuantraTM vs ROTEM Delta and routine coagulation tests in cardiac surgery

Abstract

Comparison of Quantra vs ROTEM Delta and Routine Coagulation Tests in Cardiac SurgeryFrancesco Viola1, Deborah A Winegar1, Lucas G Fernandez2, Julie L Huffmyer2, Danja S Groves21HemoSonics LLC, Charlottesville, VA, USA2University of Virginia, Charlottesville, VA, USABackground and Goal of Study: Coagulation testing is often performed in cardiac surgery and other major procedures to aid in the management of perioperative bleeding. The Quantra Hemostasis Analyzer is a novel cartridge-based viscoelastic analyzer that measures changes in clot stiffness during coagulation using ultrasound detection of resonance. The goal of this pilot study was to compare results obtained with the Quantra to the ROTEM Delta and lab based coagulation assays in cardiac patients.Materials and Methods: For each enrolled patient, citrated whole blood samples were obtained at two of three possible time points: baseline, during cardiac bypass, or after protamine administration. Measurements were performed on a research use only version of the Quantra and included Clot Time (CT), Heparinase Clot Time (CTH), Clot Stiffness (CS), Fibrinogen Contribution (FCS) and Platelet Contribution (PCS) to clot stiffness. ROTEM analysis included INTEM, HEPTEM, EXTEM, and FIBTEM assays. In addition, samples were also tested in a standard coagulation panel including PT/INR, aPTT, Clauss fibrinogen, and platelet count.Results and Discussion: A cohort of 25 patients undergoing elective cardiac surgery with cardiopulmonary bypass were enrolled in this pilot study. The Quantra was operated near patient whereas the ROTEM was placed in the blood bank. The Quantra parameters CT, CS, and FCS exhibited strong correlation with INTEM CT (r-value = 0.96), EXTEM A10 (r-value = 0.96), and FIBTEM A10 (r-value = 0.93), respectively. Strong correlation was also observed between the Quantra and conventional coagulation tests with r-values of 0.96, 0.84, and 0.90 for CT vs aPTT, FCS vs Clauss fibrinogen, and PCS vs platelet count, respectively. Complete Quantra results were available within 15 minutes of test initiation.Conclusions: The Quantra parameters demonstrated strong correlation with an established viscoelastic device as well as conventional laboratory assessment of coagulation. This study suggests that the Quantra can provide rapid and accurate assessment of coagulation function during cardiac surgery.References:Huffmyer JL, Fernandez LG, et al. Anesth. Analg.2016;123:1390-1399Naik BI, Durieux ME, et al. Anesth. Analg.2016;123:1380-1389Reynolds PS, Middleton P, et al. Anesth. Analg.2016;123:1400-1407Conflict of Interest: Francesco Viola and Deborah Winegar have an ownership interest in HemoSonics, LLC, a medical device company commercializing the Quantra System.

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