The emerging SARS-COV2 virus has shed a new light on the cross-talks between the immune and the hemostatic system. In this study we aim to evaluate the dynamic change in coagulation caused by the modulation of the inflammatory response by interleukin-6 antagonist as assessed by viscoelastic methods in critically ill COVID-19 patients. Furthermore we try to draw attention to possible associations between the endothelial cell injury, inflammation and coagulation.
The emerging SARS-COV2 virus has shed new light on the cross-talk between the immune and the hemostatic system. Pathophysiologically in COVID-19 infection the thrombo-inflammatory process is initiated by the host's exaggerated systemic inflammatory response, also called "dysregulated immune response" that activates both the inflammatory and the coagulation cascade directly by inflammatory mediators and indirectly by causing endothelial cell injury. These mechanisms altogether contribute to the imbalance of the hemostasis that is characterized by a procoagulant state. In this multicenter prospective observational study, we aim to evaluate the dynamic change in coagulation as a result of immunomodulation by interleukin-6 antagonists in critically ill COVID-19 patients. We will assess the hemostatic system by a viscoelastic hemostasis assay (Clotpro, Haemonetics Corporation, Boston). Furthermore, we try to draw attention to possible associations between endothelial cell injury, inflammation, and coagulation. To compare these parameters we will draw blood for analysis before administration of IL-6 antagonist then 24h after, 48h after, and 7 days after.
Study Type
OBSERVATIONAL
Enrollment
30
Patients will receive IL-6 antagonist therapy at the consultant's discretion.
Department of Anaesthesiology and Intensive Therapye, Medical School, University of Pécs
Pécs, Baranya, Hungary
RECRUITINGCentral Department of Anesthesiology and Intensive Care, Szent György University Teaching Hospital of County Fejér
Székesfehérvár, Fejér, Hungary
RECRUITINGDepartment of Anaesthesiology and Intensive Therapy, Pest Megyei Flór Ferenc Hospital
Kistarcsa, Pest County, Hungary
Change in the lysis time
Change of the fibrinolytic system before (T0) and after immunomodulation therapy, measured by the lysis time (LT).
Time frame: 48 hours
Change in the lysis onset time
Change of the fibrinolytic system before (T0) and after immunomodulation therapy, measured by the lysis onset time (LOT).
Time frame: 48 hours
Change in the lysis time
Change of the fibrinolytic system before (T0) and after immunomodulation therapy, measured by the lysis time (LT).
Time frame: 24 hours and 7 days
Change in the lysis onset time
Change of the fibrinolytic system before (T0) and after immunomodulation therapy, measured by the lysis onset time (LOT).
Time frame: 24 hours and 7 days
Change in Clotpro assay
Change in blood coagulation parameters which evaluate hypercoagulable state before (T0) and after immunomodulation therapy (T1,2,3) measured by Clotpro device assays.
Time frame: 24 hours, 48 hours, and 7 days
Correlation between procalcitonin and Clotpro
Correlation between inflammatory and blood coagulation parameters. For the assessment of this endpoint, we will use the results of the inflammatory laboratory parameters as procalcitonin and the blood coagulation parameters measured by the Clotpro.
Time frame: 24 hours, 48 hours, and 7 days
Correlation between C reactive protein and Clotpro
Correlation between inflammatory and blood coagulation parameters. For the assessment of this endpoint, we will use the results of the inflammatory laboratory parameters as C reactive protein and the blood coagulation parameters measured by the Clotpro.
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Time frame: 24 hours, 48 hours, and 7 days
Correlation between ferritin and Clotpro
Correlation between inflammatory and blood coagulation parameters. For the assessment of this endpoint, we will use the results of the inflammatory laboratory parameters as ferritin and the blood coagulation parameters measured by the Clotpro.
Time frame: 24 hours, 48 hours, and 7 days
Correlation between lactate dehydrogenase and Clotpro
Correlation between inflammatory and blood coagulation parameters. For the assessment of this endpoint, we will use the results of the inflammatory laboratory parameters as lactate dehydrogenase and the blood coagulation parameters measured by the Clotpro.
Time frame: 24 hours, 48 hours, and 7 days
Correlation between syndecan-1 and Clotpro
Correlation between biomarkers of endothelial injury and blood coagulation parameters. For the assessment of this endpoint, we will use the results of the biomarkers of the endothelial damage as syndecan-1 and the blood coagulation parameters measured by the Clotpro.
Time frame: 24 hours, 48 hours, and 7 days
Correlation between thrombomodulin and Clotpro
Correlation between biomarkers of endothelial injury and blood coagulation parameters. For the assessment of this endpoint, we will use the results of the biomarkers of the endothelial damage as thrombomodulin and the blood coagulation parameters measured by the Clotpro.
Time frame: 24 hours, 48 hours, and 7 days