Can nebulised HepArin Reduce morTality and time to Extubation in patients with COVID-19 Requiring invasive ventilation Meta-Trial (CHARTER-MT) : Protocol and statistical analysis plan for an investigator-initiated international meta-trial of prospective randomised clinical studies
van Haren, Frank M.P. (University of New South Wales)
Laffey, John (University Hospital Galway)
Artigas Raventós, Antoni (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Page, Clive (King's College London)
Schultz, Marcus J. (Mahidol University)
Cosgrave, David (University Hospital Galway)
McNicholas, Bairbre (University Hospital Galway)
Smoot, Thomas L. (Frederick Memorial Hospital)
Nunes, Quentin (University of Liverpool)
Richardson, Alice (Australian National University)
Yoon, Hwan-Jin (Australian National University)
van Loon, Lex M. (Australian National University)
Ghosh, Angajendra (The Northern Hospital)
Said, Simone (The Northern Hospital)
Panwar, Rakshit (John Hunter Hospital)
Smith, Roger (St Vincent's Hospital (Sydney))
Santamaria, John D. (St Vincent's Hospital (Sydney))
Dixon, Barry (St Vincent's Hospital (Sydney))
Universitat Autònoma de Barcelona

Data:	2022
Resum:	There is significant interest in the potential for nebulised unfractionated heparin (UFH), as a novel therapy for patients with COVID-19 induced acute hypoxaemic respiratory failure requiring invasive ventilation. The scientific and biological rationale for nebulised heparin stems from the evidence for extensive activation of coagulation resulting in pulmonary microvascular thrombosis in COVID-19 pneumonia. Nebulised delivery of heparin to the lung may limit alveolar fibrin deposition and thereby limit progression of lung injury. Importantly, laboratory studies show that heparin can directly inactivate the SARS-CoV-2 virus, thereby prevent its entry into and infection of mammalian cells. UFH has additional anti-inflammatory and mucolytic properties that may be useful in this context. Methods and intervention: The Can nebulised HepArin Reduce morTality and time to Extubation in Patients with COVID-19 Requiring invasive ventilation Meta-Trial (CHARTER-MT) is a collaborative prospective individual patient data analysis of on-going randomised controlled clinical trials across several countries in five continents, examining the effects of inhaled heparin in patients with COVID-19 requiring invasive ventilation on various endpoints. Each constituent study will randomise patients with COVID-19 induced respiratory failure requiring invasive ventilation. Patients are randomised to receive nebulised heparin or standard care (open label studies) or placebo (blinded placebo-controlled studies) while under invasive ventilation. Each participating study collect a pre-defined minimum dataset. The primary outcome for the meta-trial is the number of ventilator-free days up to day 28 day, defined as days alive and free from invasive ventilation.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	ARDS ; COVID-19 ; Meta-trial ; Nebulised heparin ; Pandemic ; Randomised study ; RCT ; Respiratory failure ; SARS ; SARS-CoV-2 ; Unfractionated heparin
Publicat a:	British Journal of Clinical Pharmacology, Vol. 88 Núm. 7 (july 2022) , p. 3272-3287, ISSN 1365-2125

DOI: 10.1111/bcp.15253
PMID: 35106809

16 p, 8.6 MB

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Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut d’Investigació i Innovació Parc Taulí (I3PT)
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