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Investigating the association between IL-6 antagonist therapy and blood coagulation in critically ill patients with
Emőke Henrietta Kovács1,2,3, Máté Rottler4, Fanni Dembrovszky1,5
1Centre for Translational Medicine, Semmelweis University, Budapest, Hungary.
Insights
This study investigates how Interleukin-6 (IL-6) antagonist therapy impacts blood coagulation in critically ill COVID-19 patients. Researchers assessed changes in viscoelastic parameters to understand the therapy
Area of Science:
- Critical care medicine
- Hematology
- Immunology
Background:
- COVID-19 is characterized by hypercoagulation, driven by a hyperinflammatory response that disrupts hemostasis.
- Interleukin-6 (IL-6) antagonist therapy is used in select critically ill COVID-19 patients to manage inflammation.
- The interplay between immune responses and hemostasis is significant.
Purpose of the Study:
- To determine if IL-6 antagonist therapy alters whole blood coagulation in critically ill COVID-19 patients.
- To evaluate changes in viscoelastic parameters of blood coagulation following immunomodulation.
Main Methods:
- Prospective observational study design.
- Data collection on inflammatory markers and blood coagulation using the ClotPro® device.
- Assessment of fibrinolytic system changes (Lysis Time, Lysis onset time) at multiple time points before and after IL-6 antagonist administration.
Main Results:
- Primary outcome: changes in fibrinolysis parameters (Lysis Time, Lysis onset time).
- Secondary outcomes: alterations in other coagulation parameters and endothelial injury biomarkers.
- Data collected at baseline (T0) and at 24, 48 hours, and days 5 and 7 (T1-4) post-therapy.
Conclusions:
- The study aims to elucidate the hemostatic effects of IL-6 blockade in COVID-19.
- Findings will contribute to understanding the complex relationship between inflammation and coagulation in severe COVID-19.
- Results will be disseminated via peer-reviewed publications.
Introduction:
Hypercoagulation is one the main features of COVID-19. It is induced by the hyperinflammatory response that shifts the balance of haemostasis towards pro-coagulation. Interleukin-6 (IL-6) antagonist therapy has been recommended in certain subgroups of critically ill patients with COVID-19 to modulate inflammatory response. The interaction between immune response and haemostasis is well recognised. Therefore, our objective is to evaluate whether the modulation of the inflammatory response by IL-6 antagonist inflicts any changes in whole blood coagulation as assessed by viscoelastic methods in critically ill patients with COVID-19.
Methods And Analysis:
In this prospective observational study, we are going to collect data on inflammatory parameters and blood coagulation using the ClotPro® device. The primary outcome is the change of the fibrinolytic system measured by the Lysis Time and Lysis onset time before and after immunomodulation therapy. Data will be collected before the IL-6 antagonist administration at baseline (T0) then after 24, 48 hours, then on day 5 and 7 (T1-4, respectively). Secondary outcomes include changes in other parameters related to inflammation, blood coagulation and biomarkers of endothelial injury.
Ethics And Dissemination:
Ethical approval was given by the Medical Research Council of Hungary (1405-3/2022/EÜG). All participants provided written consent. The results of the study will be disseminated through peer-reviewed journals.
Trial Registration Number:
NCT05218369; Clinicaltrials.gov.
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