An observational study in COVID-19 and Critical Illness, sponsored by University of Pecs. Status unknown at 3 sites in Hungary. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-04-20.
Sponsored by University of Pecs · Observational
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 30 is below the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →University of Pecs is the lead sponsor of 100 studies on the registry; 24 are open to participants now.
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All adult patients admitted to intensive care units (ICUs) requiring mechanical ventilation with proven COVID-19 infection and treated with interleukin-6 antagonist therapy.
Exclusion Criteria:
Patients in ICU due to critical COVID-19 infection, who receive early (within the first 24 hours, but no later than 48 hours after intubation) IL-6 antagonist therapy at the consultant's discretion.
Drug: IL6 Antagonist
Patients will receive IL-6 antagonist therapy at the consultant's discretion.
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.
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
Plan to share: No — Data will be presented at conferences and in the results part of the article.
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University of Pecs