Study name |
Nebulised heparin in patients with severe COVID‐19 (CHARTER‐MT) |
Starting date |
01 November 2020 |
Contact information |
Frank MP van Haren, MD, PhD Australian National University Helwan University Clinica San Camilo, Argentina +61467051809 | frank.vanharen@anu.edu.au
|
Methods |
Randomised clinical trial |
Participants |
712 participants, ≥ 18 years, female and male
Age ≥ 18 years
Currently in an ICU or scheduled for transfer to the ICU. During the pandemic, critically ill inpatients might be cared for outside of the walls of the usual physical environment of ICU. For this reason, ICU is defined as an area designated for inpatient care of the critically ill where therapies including invasive mechanical ventilation can be provided.
Endotracheal tube in place
Intubated current or previous day
PaO2 to FIO2 ratio ≤ 300 while intubated
Acute opacities not fully explained by effusions, lobar/lung collapse and nodules, affecting at least 1 lung quadrant on chest X‐ray or CT
The acute opacities on chest X‐ray or CT are most likely due to COVID‐19
There is a PCR‐positive sample for SARS‐CoV‐2 within the past 21 days or there are results pending or further testing is planned. The sample can be a nasal or pharyngeal swab, sputum, tracheal aspirate, bronchoalveolar lavage, or another sample from the patient
|
Interventions |
Nebulised UFH (25,000 Units in 5 mL) will be administered 6‐hourly via an Aerogen Solo vibrating mesh nebuliser while patients receive invasive mechanical ventilation in ICU and for a maximum of 10 days |
Outcomes |
Primary
Alive and ventilator‐free score (time frame: day 28). Validated hierarchical composite endpoint, based on mortality and ventilator‐free days, which is less prone to favour a treatment with discordant effects on survival and days free of ventilation
|
Notes |
NCT04635241 | No data provided |