University Hospital Galway
Galway, Ireland
NCT Number: NCT04511923
The investigators present a randomised open label phase Ib/IIa trial of nebulised unfractionated heparin to evaluate the effect of nebulised unfractionated heparin on the procoagulant response in ICU patients with SARS-CoV-2 requiring advanced respiratory support. As this is one of the first studies of nebulised heparin in COVID 19 lung disease the investigators will assess safety as a co-primary outcome.
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Notify Me18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Galway, Ireland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
To be eligible, a patient must satisfy all these inclusion criteria:
Exclusion criteria
To be eligible, a patient must have none of these exclusion criteria:
Nebulised unfractionated heparin 25000 units administered 6 hourly for 10 days
Time frame: Up to day 10.
Effect of nebulised heparin on d-dimer profile, assessed via d-dimer AUC and via a mixed effects model, with data collected on days 1, 3, 5 and 10.
Time frame: Up to day 60
Safety of nebulised heparin delivered by aerogen solo nebuliser in patients with COVID-19 induced severe respiratory failure, as measured by the incidence of severe adverse events.
Time frame: Up to day 10
Determine the impact of nebulised heparin on oxygenation index
Time frame: Up to day 10
Effect of nebulised heparin on indices of inflammation (Interleukin (IL)-1β, IL-6, IL-8, IL-10 and soluble TNF receptor 1 (sTNFR1), C-reactive protein, procalcitonin, Ferritin,) will be assessed (AUC on days 1, 3, 5 and 10)
Time frame: Up to day 10
Effect of nebulised heparin on the ratios of IL-1β/IL-10 and IL-6/IL-10 will also be assessed.
Time frame: Up to day 10
Effect of nebulised heparin on other indices of coagulation (Fibrinogen; lactate dehydrogenase) will be assessed (AUC on days 1, 3, 5 and 10).
Time frame: Up to day 10
Determine the effect of nebulised heparin on Quasi-Static Lung Compliance (i.e. tidal volume/(Plateau pressure-PEEP) measured on days 1,3,5,10.
Time frame: Up to day 28
Time to separation from advanced respiratory support, where non survivors are treated as though not separated from advanced respiratory support.
Time frame: Up to day 10
Number treated with neuromuscular blockers instituted after enrolment
Time frame: Up to day 10
Number treated with prone positioning instituted after enrolment
Time frame: Up to day 10
Number treated with extra-corporeal membrane oxygenation instituted after enrolment
Time frame: Up to day 28
Number tracheotomised
Time frame: Up to day 28
Time to separation from invasive ventilation among survivors
Time frame: Up to day 28
Time to separation from the ICU to day 28, where non-survivors to day 28 are treated as though not separated from invasive care
Time frame: Up to day 28
Time to discharge from the ICU to day 28, among survivors
Time frame: Up to day 60
Survival to day 28; Survival to day 60; and Survival to hospital discharge, censored at day 60
Time frame: Up to day 60
Number residing at home or in a community setting at day 60
Time frame: Up to day 60
Number residing at home or in a community setting at day 60, among survivors
Time frame: Up to day 10
Effect of nebulised heparin on ventilatory ratio measured every 6 hours
Time frame: Up to day 10
Number of patients treated with awake prone positioning
University College Hospital Galway
Other
Can Nebulised HepArin Reduce acuTE Lung Injury in Patients With SARS-CoV-2 Requiring Respiratory Support in Ireland
Acronym: CHARTER-Irl
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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