• Philip Toner, Andrew J Boyle, James J McNamee, Kathryn Callaghan, Christopher Nutt, Paul Johnston, John Trinder, Margaret McFarland, Rejina Verghis, Daniel F McAuley, and Cecilia M O'Kane.
• Wellcome-Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, Northern Ireland; Royal Victoria Hospital, Belfast Health and Social Care Trust, Belfast, Northern Ireland. Electronic address: philip.toner@belfasttrsut.hscni.net.
• Chest. 2022 May 1; 161 (5): 127512841275-1284.

BackgroundThere is no pharmacologic treatment for ARDS. Platelets play an important role in the pathophysiology of ARDS. Preclinical, observational, and clinically relevant models of ARDS indicate aspirin as a potential therapeutic option.Research QuestionIs enteral aspirin (75 mg, once daily) safe and effective in improving surrogate outcomes in adult patients with ARDS?Study Design And MethodsThis randomized, double-blind (patient and investigator), allocation-concealed, placebo-controlled phase 2 trial was conducted in five UK ICUs. Patients fulfilling the Berlin definition of ARDS were randomly assigned at a 1:1 ratio to receive enteral aspirin (75 mg) or placebo, for a maximum of 14 days, using a computer-generated randomization schedule, with variable block size, stratified by vasopressor requirement. The primary end point was oxygenation index (OI) on day 7. Secondary outcomes included safety parameters and other respiratory physiological markers. Analyses were by intention to treat.ResultsThe trial was stopped early, due to slow recruitment, after 49 of a planned 60 patients were recruited. Twenty-four patients were allocated to aspirin and 25 to placebo. There was no significant difference in day 7 OI [aspirin group: unadjusted mean, 54.4 (SD 26.8); placebo group: 42.4 (SD 25); mean difference, 12.0; 95% CI, -6.1 to 30.1; P = .19]. Aspirin did not significantly impact the secondary outcomes. There was no difference in the number of adverse events between the groups (13 in each; OR, 1.04; 95% CI, 0.56-1.94; P = .56).InterpretationAspirin was well tolerated but did not improve OI or other physiological outcomes; a larger trial is not feasible in its current design.Trial RegistrationClinicalTrials.gov; No.: NCT02326350; URL: www.Clinicaltrialsgov.Crown Copyright © 2021. Published by Elsevier Inc. All rights reserved.

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