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ClotPro Viscoelastometry Evaluation in Cardiac Surgery With Cardiopulmonary Bypass

Published:November 24, 2022DOI:https://doi.org/10.1053/j.jvca.2022.11.022

      Objective

      The aim of this study was to assess the reproducibility of the new viscoelastic analyzer ClotPro, and compare the parameters this system produces with the ROTEM delta system in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB).

      Design

      A prospective and observational study.

      Setting

      At a university hospital.

      Participants

      Forty adult patients undergoing cardiac surgery with CPB.

      Interventions

      Correlations were calculated between ClotPro and ROTEM delta parameters.

      Measurements and Main Results

      The ClotPro showed a high reproducibility in most of the parameters of each test; whereas ROTEM delta, although showing a low coefficient of variation in the parameters related to clot firmness, showed a high variability in the coagulation times. Excellent correlations were observed in most of the parameters of each test between ROTEM delta and ClotPro (≥0.93). However, a moderate correlation was obtained between the clotting time of the EXTEM and the EX-test (0.54). The concordance of amplitudes at different times within each test was almost 100% on both thromboelastometers. Regarding absolute differences in the test results, most of the measurements showed significant differences (p < 0.0001) between both devices.

      Conclusions

      ClotPro can be used as an alternative to ROTEM delta to evaluate coagulation function in cardiac surgery, but specific reference ranges need to be established first.

      Key Words

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      References

        • De Robertis E
        • Kozek-Langenecker SA
        • Tufano R
        • et al.
        Coagulopathy induced by acidosis, hypothermia and hypocalcaemia in severe bleeding.
        Minerva Anestesiol. 2015; 81: 65-75
        • Meesters MI
        • von Heymann C.
        Optimizing perioperative blood and coagulation management during cardiac surgery.
        Anesthesiol Clin. 2019; 37: 713-728
        • Ranucci M
        • Baryshnikova E
        • Castelvecchio S
        • et al.
        Major bleeding, transfusions, and anemia: The deadly triad of cardiac surgery.
        Ann Thorac Surg. 2013; 96: 478-485
        • Sniecinski R
        • Szlam F
        • Chen EP
        • et al.
        Antithrombin deficiency increases thrombin activity after prolonged cardiopulmonary bypass.
        Anesth Analg. 2008; 106 (table of contents): 713-718
        • Whiting D
        • DiNardo JA.
        TEG and ROTEM: Technology and clinical applications.
        Am J Hematol. 2014; 89: 228-232
        • Theusinger OM
        • Nürnberg J
        • Asmis LM
        • et al.
        Rotation thromboelastometry (ROTEM) stability and reproducibility over time.
        Eur J Cardiothorac Surg. 2010; 37: 677-683
        • World Medical Association
        World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects.
        JAMA. 2013; 310: 2191-2194
      1. US Food and Drug Administration. E6(R2) Good clinical practice: Integrated addendum to ICH E6 (R1). Available at: https://www.fda.gov/media/93884/download. Accessed September 10, 2019.

        • Koo TK
        • Li MY.
        A guideline of selecting and reporting intraclass correlation coefficients for reliability research.
        J Chiropr Med. 2016; 15: 155-163
        • Bland JM
        • Altman DG.
        Measuring agreement in method comparison studies.
        Stat Methods Med Res. 1999; 8: 135-160
        • Walter SD
        • Eliasziw M
        • Donner A.
        Sample size and optimal designs for reliability studies.
        Stat Med. 1998; 17: 101-110
        • Ebinger T.
        • Concerning Hänecke P
        • Klouche M
        Thrombelastography today: Practicability and analytical power.
        Transfus Med Hemother. 2007; 34 (Transfus Med 2008;35:324-6): 421-428
        • Nagler M
        • ten Cate H
        • Kathriner S
        • et al.
        Consistency of thromboelastometry analysis under scrutiny: Results of a systematic evaluation within and between analysers.
        Thrombo Haemost. 2014; 111: 1161-1166
        • Hartmann J
        • Murphy M
        • Dias JD.
        Viscoelastic hemostatic assays: Moving from the laboratory to the site of care-a review of established and emerging technologies.
        Diagnostics (Basel). 2020; 10: 118
        • Görlinger K
        • Dirkmann D
        • Hanke AA.
        Rotational thromboelastometry (ROTEM).
        in: Gonzalez E Moore HB Moore EE Trauma Induced Coagulopathy. First edition. Springer International Publishing, Cham, Switzerland2016: 267-298
        • Görlinger K
        • Dirkmann D
        • Hanke AA.
        Rotational thromboelastometry (ROTEM).
        in: Moore HB Moore EE Neal MD Trauma Induced Coagulopathy. Second edition. Springer International Publishing, Cham, Switzerland2021: 279-312