Nebulised heparin for patients with or at risk of acute respiratory distress syndrome: a multicentre, randomised, double-blind, placebo-controlled phase 3 trial
Barry Dixon, Roger J Smith, Duncan J Campbell, John L Moran, Gordon S Doig, Thomas Rechnitzer, Christopher M MacIsaac, Nicholas Simpson, Frank MP van Haren, Angajendra N Ghosh, Sachin Gupta, Emma JC Broadfield, Timothy ME Crozier, Craig French, John D Santamaria
LANCET RESPIRATORY MEDICINE | ELSEVIER SCI LTD | Published : 2021
BACKGROUND: Mechanical ventilation in intensive care for 48 h or longer is associated with the acute respiratory distress syndrome (ARDS), which might be present at the time ventilatory support is instituted or develop afterwards, predominantly during the first 5 days. Survivors of prolonged mechanical ventilation and ARDS are at risk of considerably impaired physical function that can persist for years. An early pathogenic mechanism of lung injury in mechanically ventilated, critically ill patients is inflammation-induced pulmonary fibrin deposition, leading to thrombosis of the microvasculature and hyaline membrane formation in the air sacs. The main aim of this study was to determine if n..View full abstract
We wish to acknowledge financial support provided by the Rowe Family Foundation, TR and RB Ditchfield Medical Research Endowment Fund, Patricia Madigan Charitable Trust, and The J and R McGauran Trust Fund (Sydney, NSW, Australia). We are grateful to Aerogen Ltd (Galway, Ireland) who supplied nebuliser equipment at no cost. We thank the members of the Data Safety Monitoring Board led by Matthew Anstey. For their assistance with the purchase and masking of the study drug we are grateful to Daniel Lim and Yves Lorenzo. For his assistance developing and managing the study database we thank David Reid. For their assistance with preparation of funding applications we thank Robert Duncan Hite and Marcus Schultz. This work is dedicated to the study patients and their families, and to our own families and colleagues.