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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; Laffey, John G; Artigas, Antonio; Page, Clive; Schultz, Marcus J; Cosgrave, David; McNicholas, Bairbre; Smoot, Thomas L; Nunes, Quentin; Richardson, Alice; Yoon, Hwan-Jin; van Loon, Lex M; Ghosh, Angajendra; Said, Simone; Panwar, Rakshit; Smith, Roger; Santamaria, John D; Dixon, Barry.
  • van Haren FMP; Australian National University, Canberra, Australia.
  • Laffey JG; University of New South Wales, Sydney, Australia.
  • Artigas A; Intensive Care Unit, St George Hospital, Sydney, Australia.
  • Page C; Anaesthesia and Intensive Care Medicine, School of Medicine, and Regenerative Medicine Institute (REMEDI) at CÚRAM Centre for Research in Medical Devices, Biomedical Sciences Building, National University of Ireland Galway, Galway, Ireland.
  • Schultz MJ; Department of Anaesthesia, University Hospital Galway, Saolta Hospital Group, Ireland.
  • Cosgrave D; Critical Center, Corporació Sanitaria Parc Tauli, CIBER Enfermedades Respiratorias, Autonomous University of Barcelona, Sabadell, Spain.
  • McNicholas B; Sackler Institute of Pulmonary Pharmacology, King's College London, UK.
  • Smoot TL; Department of Intensive Care, Amsterdam University Medical Centre, Amsterdam, the Netherlands.
  • Nunes Q; Nuffield Department of Medicine, Oxford University, Oxford, UK.
  • Richardson A; Mahidol-Oxford Tropical Medicine Research Unit, Mahidol University, Bangkok, Thailand.
  • Yoon HJ; Department of Anaesthesia, University Hospital Galway, Saolta Hospital Group, Ireland.
  • van Loon LM; Department of Anaesthesia, University Hospital Galway, Saolta Hospital Group, Ireland.
  • Ghosh A; Frederick Memorial Hospital, Frederick, Maryland, USA.
  • Said S; Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, UK.
  • Panwar R; Australian National University, Canberra, Australia.
  • Smith R; Australian National University, Canberra, Australia.
  • Santamaria JD; Australian National University, Canberra, Australia.
  • Dixon B; Intensive Care Unit, The Northern Hospital, Melbourne, Australia.
Br J Clin Pharmacol ; 88(7): 3272-3287, 2022 07.
Article in English | MEDLINE | ID: covidwho-1666292
ABSTRACT
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Respiratory Insufficiency / Noninvasive Ventilation / COVID-19 Drug Treatment Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials / Reviews Limits: Humans Language: English Journal: Br J Clin Pharmacol Year: 2022 Document Type: Article Affiliation country: Bcp.15253

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Respiratory Insufficiency / Noninvasive Ventilation / COVID-19 Drug Treatment Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials / Reviews Limits: Humans Language: English Journal: Br J Clin Pharmacol Year: 2022 Document Type: Article Affiliation country: Bcp.15253