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Abstract
Background
The aim of this study was to assess changes in hemostasis and associated outcome of hospitalized patients with COVID-19 infection and mild hypoxemia.
Methods
Adult patients with COVID-19 infection and hypoxemia admitted to ICU were included in this prospective observational study. The primary outcome was defined as an unfavorable course of the disease if a patient: (1) developed a thromboembolic event while receiving anticoagulation prophylaxis, (2) had prolonged ICU stay, or (3) died. Demographic data, laboratory parameters and thromboelastometry (ROTEM) test results were collected.
Results
Twenty-five patients were recruited into the study. There were 16 patients with an unfavorable course of the disease. Compared to the 9 patients in the favorable course group, patients with an unfavorable course had a lower platelet count, median difference of 154 (95% CI, 26 to 223 x109/L), P = 0.012, and lower clot firmness parameters in EXTEM assay: amplitude at 20 minutes (A20), median difference of 7 (95% CI, 2 to 11) P = 0.006, maximum clot firmness (MCF), median difference of 6 (95% CI, 3 to 10) P = 0.006 and area under the curve (AUC) with a median difference of 671 (95% CI, 244 to 1029) P = 0.005. They also demonstrated suppression of fibrinolysis: higher lysis index 60, median difference of −3 (95% CI, −6 to 0), P = 0.023. Results of functional fibrinogen (FIBTEM) assay were similar between the groups.
Conclusion
The platelet count and the results of EXTEM assay, but not FIBTEM assay, were associated with the difference in clinical outcome among patients with COVID-19 infection and hypoxemia. The role of platelets in the outcome of COVID-19 infection calls for further investigation. Future studies on adjusting anticoagulant therapy based on the results of viscoelastic testing may be beneficial.
Abbreviations
ALP, alpha angle; A10, amplitude 10 minutes after clotting time; CCT, conventional coagulation tests; CFT, clot formation time; COPD, chronic obstructive pulmonary disease; COVID-19, coronavirus disease 2019; CT, clotting time; DVT, deep vein thrombosis; ICU, intensive care unit; INR, international normalized ratio; LI60, lysis index 60 minutes after clotting time; Max V, maximum velocity; MaxV-t, time to maximum velocity; MCF, maximum clot firmness; ML, maximum lysis; ROTEM, rotational thromboelastometry; STROBE, Strengthening the Reporting of Observational Studies in Epidemiology; TEG, thromboelastogram.
Data Sharing Statement
All data generated or analyzed during this study are included in this published article.
Ethics Approval
This study was approved by the Lifespan Institutional Review Board (IRB# 1591584, October 27, 2020). Our study conforms to provisions of the Declaration of Helsinki. Written consent was obtained from all participants.
Acknowledgments
We are thankful to Instrumentation Laboratory for providing the reagents for the ROTEM analysis used in the study. The laboratory had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Author Contributions
All authors made substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; took part in drafting the article or revising it critically for important intellectual content; agreed to submit to the current journal; gave final approval of the version to be published; and agree to be accountable for all aspects of the work.
Disclosure
Dr. Klaus Görlinger has been the Medical Director of TEM Innovations GmbH, Munich, Germany since 2012 and reports no other potential conflicts of interest in relation to this work. All other authors (DS, MCK, AL, RS, DP, and GDO) report no conflicts of interest in relation to this work.