Accuracy of a point-of-care CoaguChek test versus
standard laboratory coagulation monitoring in cardiac
surgery involving cardiopulmonary bypass: randomized
clinical trial

Fabrício Tavares Mendonça; Sérgio Honorato de Matos; Larissa Goveia Moreira; Igor Louza Pereira; Lorenzo Leite Dino; Matheus Beserra Braga; Gustavo Henrique dos Santos Dias

doi:10.1016/j.bjane.2025.844714

Original Investigation

Accuracy of a point-of-care CoaguChek test versus standard laboratory coagulation monitoring in cardiac surgery involving cardiopulmonary bypass: randomized clinical trial

Acurácia do teste point-of-care CoaguChek versus monitorização laboratorial padrão da coagulação em cirurgia cardíaca com circulação extracorpórea: ensaio clínico randomizado

Fabrício Tavares Mendonça, Sérgio Honorato de Matos, Larissa Goveia Moreira, Igor Louza Pereira, Lorenzo Leite Dino, Matheus Beserra Braga, Gustavo Henrique dos Santos Dias

http://dx.doi.org/10.1016/j.bjane.2025.844714 Braz J Anesthesiol, vol.76, n2, 844714, 2025

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Abstract

Background

Intraoperative coagulopathies are common in complex surgeries, and timely coagulation monitoring is crucial. We assessed the accuracy of the point-of-care CoaguChek XS test against standard laboratory measurements in patients undergoing cardiac surgery with Cardiopulmonary Bypass (CPB).

Methods

We conducted a single-center, diagnostic accuracy study to assess the coagulation profile of 50 participants before and after CPB. The index test was the CoaguChek XS device and the reference test was the standard laboratory assay. The primary outcome was the accuracy of the CoaguChek device in measuring the International Normalized Ratio (INR). We pre-specified a tolerance range of § 0.5 INR units. Secondary outcomes included accuracy in measuring prothrombin time and prothrombin activity.

Results

We included 50 patients undergoing cardiac surgery with CPB between October 2023 and January 2024. The mean (standard deviation) age was 59.2 (12.3) years, and 32 participants (64%) were male. For INR values, Lin’s coefficient was 0.72 (95% CI: 0.60‒0.82) pre-CPB and 0.66 (95% CI: 0.50‒0.77) post-CPB, both indicating good agreement. In the pre-CPB period, on average, the index test readings exceeded reference readings by 0.045 INR units (95% CI: 0.030‒0.059, p < 0.001), while in post-CPB period, index readings were, on average, 0.064 INR units lower (95% CI: -0.09 to -0.04, p < 0.001). Although statistically significant differences were observed, they fell within predefined tolerance range and were considered clinically irrelevant. Analyses of secondary outcomes were consistent with the primary outcome findings.

Conclusion

In patients undergoing cardiac surgery with cardiopulmonary bypass, CoaguChek XS provided results comparable to standard laboratory coagulation monitoring, both pre-and postcardiopulmonary bypass.

Clinical Trials Registration

(https://clinicaltrials.gov/study/NCT06037720) NCT06037720, 14/09/2023.

Research Board Approval

Plataforma Brasil CAAE 70266023.8.0000.5553.

Keywords

Blood coagulation tests; Cardiopulmonary bypass; Diagnostic, point of care; International normalized ratio

Resumo

Indtrodução

Coagulopatias intraoperatórias são comuns em cirurgias complexas, e a monitorização oportuna da coagulação é crucial. Avaliamos a acurácia do teste point-of-care CoaguChek XS em comparação com medições laboratoriais padrão em pacientes submetidos à cirurgia cardíaca com circulação extracorpórea (CEC).

Metódos

Realizamos um estudo unicêntrico de acurácia diagnóstica para avaliar o perfil de coagulação de 50 participantes antes e após a CEC. O teste índice foi o dispositivo CoaguChek XS e o teste de referência foi o ensaio laboratorial padrão. O desfecho primário foi a acurácia do dispositivo CoaguChek na mensuração da Razão Normalizada Internacional (RNI). Foi previamente especificada uma faixa de tolerância de ± 0,5 unidades de RNI. Os desfechos secundários incluíram a acurácia na mensuração do tempo de protrombina e da atividade de protrombina.

Resultados

Foram incluídos 50 pacientes submetidos à cirurgia cardíaca com CEC entre outubro de 2023 e janeiro de 2024. A idade média (desvio padrão) foi de 59,2 (12,3) anos, e 32 participantes (64%) eram do sexo masculino. Para os valores de RNI, o coeficiente de Lin foi de 0,72 (IC 95%: 0,60‒0,82) no pré-CEC e 0,66 (IC 95%: 0,50‒0,77) no pós-CEC, ambos indicando boa concordância. No período pré-CEC, em média, as leituras do teste índice excederam as do teste de referência em 0,045 unidades de RNI (IC 95%: 0,030‒0,059; p < 0,001), enquanto no período pós-CEC, as leituras do teste índice foram, em média, 0,064 unidades de RNI menores (IC 95%: -0,09 a -0,04; p < 0,001). Embora diferenças estatisticamente significativas tenham sido observadas, estas permaneceram dentro da faixa de tolerância previamente definida e foram consideradas clinicamente irrelevantes. As análises dos desfechos secundários foram consistentes com os achados do desfecho primário.

Conclusão

Em pacientes submetidos à cirurgia cardíaca com circulação extracorpórea, o CoaguChek XS forneceu resultados comparáveis à monitorização laboratorial padrão da coagulação, tanto no pré quanto no pós-circulação extracorpórea.

Aprovação do Comitê de Ética em Pesquisa

Plataforma Brasil CAAE 70266023.8.0000.5553.

Registro de Ensaios Clínicos

(https://clinicaltrials.gov/study/NCT06037720) NCT06037720, 14/09/2023.

Palavras-chave

Testes de coagulação sanguínea; Circulação extracorpórea; Diagnóstico point-of-care; Razão normalizada internacional

Referencias

1. Vivacqua A, Koch CG, Yousuf AM, et al. Morbidity of bleeding after cardiac surgery: is it blood transfusion, reoperation for bleeding, or both? Ann Thorac Surg. 2011;91:1780−90.

2. Bolliger D, Gorlinger K, Tanaka KA. Pathophysiology and treat- € ment of coagulopathy in massive hemorrhage and hemodilution. Anesthesiology. 2010;113:1205−19.

3. Dusse LMS, Oliveira NC, Rios DRA, Marcolino MS. Point-of-care test (POCT) INR: hope or illusion? Rev Bras Cir Cardiovasc. 2012;27:296−301.

4. Vieira AC, Arnoni RT, Barbosa ABS, Berriel AS, Vianna RG, Issa M. Predictive Factors for Bleeding Risk in Patients Undergoing Valvular Surgery. Arq Bras Cardiol. 2024;121:e20230453.

5. Guede-Fernandez F, Pinto TS, Semedo H, et al. Enhancing post- operative anticoagulation therapy with remote patient monitoring: A pilot crossover trial study to evaluate portable coagulometers and chatbots in cardiac surgery follow-up. Digit Health. 2024;10:20552076241269515.

6. Bardakci H, Alt{ntas G, ¸ Ci ¸ cek OF, et al. Comparison of the Coa- ¸ guChek XS handheld coagulation analyzer and conventional laboratory methods measuring international normalised ratio (INR) values during the time to therapeutic range after mechanical valve surgery. J Card Surg. 2013;28:254−7.

7. Bolliger D, Seeberger MD, Tanaka KA. Principles and practice of thromboelastography in clinical coagulation management and transfusion practice. Transfus Med Rev. 2012;26:1−13.

8. Weber CF, Klages M, Zacharowski K. Perioperative coagulation management during cardiac surgery. Curr Opin Anaesthesiol. 2013;26:60−4.

9. Cohen JF, Korevaar DA, Altman DG, et al. STARD 2015 guidelines for reporting diagnostic accuracy studies: explanation and elaboration. BMJ Open. 2016;6:e012799.

10. Benade EL, Jacobson BF, Louw S, Schapkaitz E. Validation of the CoaguChek XS international normalised ratio point-of-care analyser in patients at Charlotte Maxeke Johannesburg Academic Hospital. South Africa. S Afr Med J. 2016;106:280−3.

11. Kottner J, Audige L, Brorson S, et al. Guidelines for Reporting Reliability and Agreement Studies (GRRAS) were proposed. Int J Nurs Stud. 2011;48:661−71.

12. Gerke O. Reporting Standards for a Bland-Altman Agreement Analysis: A Review of Methodological Reviews. Diagnostics (Basel). 2020;10:334.

13. Lin LI. A concordance correlation coefficient to evaluate reproducibility. Biometrics. 1989;45:255−68.

14. Mahon G. A Proposal for Strength-of-Agreement Criteria for Lin’s Concordance Correlation Coefficient. 2005.

15. Okabayashi S, Ogawa S, Tanaka KA, et al. A Comparative Study of Point-of-Care Prothrombin Time in Cardiopulmonary Bypass Surgery. J Cardiothorac Vasc Anesth. 2018;32:1609−14.

16. Urwyler N, Staub LP, Beran D, et al. Is perioperative point-ofcare prothrombin time testing accurate compared to the standard laboratory test? Thromb Haemost. 2009;102:779−86.

17. Meesters MI, Kuiper G, Vonk ABA, Loer SA, Boer C. Validation of a point-of-care prothrombin time test after cardiopulmonary bypass in cardiac surgery. Anaesthesia. 2016;71:1163−8.

18. Hoel RW, Albright RC, Beyer LK, et al. Correlation of point-ofcare International Normalized Ratio to laboratory International Normalized Ratio in hemodialysis patients taking warfarin. Clin J Am Soc Nephrol. 2009;4:99−104.

19. Dias JD, Sauaia A, Achneck HE, Hartmann J, Moore EE. Thromboelastography-guided therapy improves patient blood management and certain clinical outcomes in elective cardiac and liver surgery and emergency resuscitation: A systematic review and analysis. J Thromb Haemost. 2019;17:984−94.

Submitted date:
03/03/2025

Accepted date:
07/11/2025