Investigating the association between IL-6 antagonist therapy and blood coagulation in critically ill patients with COVID-19: a protocol for a prospective, observational, multicentre study

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...

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Autores principales: Kovács, Emőke Henrietta, Rottler, Máté, Dembrovszky, Fanni, Ocskay, Klementina, Szabó, László, Hegyi, Péter, Molnár, Zsolt, Tánczos, Krisztián
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9638747/
https://www.ncbi.nlm.nih.gov/pubmed/36332964
http://dx.doi.org/10.1136/bmjopen-2022-063856
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author Kovács, Emőke Henrietta
Rottler, Máté
Dembrovszky, Fanni
Ocskay, Klementina
Szabó, László
Hegyi, Péter
Molnár, Zsolt
Tánczos, Krisztián
author_facet Kovács, Emőke Henrietta
Rottler, Máté
Dembrovszky, Fanni
Ocskay, Klementina
Szabó, László
Hegyi, Péter
Molnár, Zsolt
Tánczos, Krisztián
author_sort Kovács, Emőke Henrietta
collection PubMed
description 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 (T(0)) then after 24, 48 hours, then on day 5 and 7 (T(1-4), 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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spelling pubmed-96387472022-11-07 Investigating the association between IL-6 antagonist therapy and blood coagulation in critically ill patients with COVID-19: a protocol for a prospective, observational, multicentre study Kovács, Emőke Henrietta Rottler, Máté Dembrovszky, Fanni Ocskay, Klementina Szabó, László Hegyi, Péter Molnár, Zsolt Tánczos, Krisztián BMJ Open Intensive Care 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 (T(0)) then after 24, 48 hours, then on day 5 and 7 (T(1-4), 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. BMJ Publishing Group 2022-11-04 /pmc/articles/PMC9638747/ /pubmed/36332964 http://dx.doi.org/10.1136/bmjopen-2022-063856 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Intensive Care
Kovács, Emőke Henrietta
Rottler, Máté
Dembrovszky, Fanni
Ocskay, Klementina
Szabó, László
Hegyi, Péter
Molnár, Zsolt
Tánczos, Krisztián
Investigating the association between IL-6 antagonist therapy and blood coagulation in critically ill patients with COVID-19: a protocol for a prospective, observational, multicentre study
title Investigating the association between IL-6 antagonist therapy and blood coagulation in critically ill patients with COVID-19: a protocol for a prospective, observational, multicentre study
title_full Investigating the association between IL-6 antagonist therapy and blood coagulation in critically ill patients with COVID-19: a protocol for a prospective, observational, multicentre study
title_fullStr Investigating the association between IL-6 antagonist therapy and blood coagulation in critically ill patients with COVID-19: a protocol for a prospective, observational, multicentre study
title_full_unstemmed Investigating the association between IL-6 antagonist therapy and blood coagulation in critically ill patients with COVID-19: a protocol for a prospective, observational, multicentre study
title_short Investigating the association between IL-6 antagonist therapy and blood coagulation in critically ill patients with COVID-19: a protocol for a prospective, observational, multicentre study
title_sort investigating the association between il-6 antagonist therapy and blood coagulation in critically ill patients with covid-19: a protocol for a prospective, observational, multicentre study
topic Intensive Care
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9638747/
https://www.ncbi.nlm.nih.gov/pubmed/36332964
http://dx.doi.org/10.1136/bmjopen-2022-063856
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