6/28/23, 9:57 PM EOLIA Pathway Feedback Search Clinical Topics Home Studies EOLIA EOLIA Disease Acute respiratory distress syndr Trial question What is the role of ECMO in patients with severe ARDS? Study design Multi-center Open label RCT Population Characteristics of study participants 29.0% female N = 249 71.0% male 249 patients (72 female, 177 male) Inclusion criteria: patients with very severe ARDS, as indicated by one of three criteria - a ratio of partial pressure of arterial oxygen to the FiO2 < 50 mmHg for > 3 hours; a ratio of partial pressure of arterial oxygen to the FiO2 < 80 mmHg for > 6 hours; or an arterial blood pH < 7.25 with a partial pressure of arterial CO2 of at least 60 mmHg for > 6 hours Key exclusion criteria: age < 18 years; receipt of mechanical ventilation for 7 days; pregnancy; long-term chronic respiratory insufficiency treated with oxygen therapy or noninvasive ventilation; cardiac failure resulting in venoarterial ECMO; a history of heparin- induced thrombocytopenia; cancer with a life expectancy < 5 years; a moribund condition Interventions N=124 ECMO (percutaneous venovenous cannulation within 2 hours of randomization) N=125 control (continued conventional treatment) Primary outcome https://web.pathway.md/studies/reci6YNhAbxGHOxeP 1/2 6/28/23, 9:57 PM EOLIA Pathway Death at 60 days 46.0 % 46 35 34.5 % 23.0 % 11.5 % No significant difference 0.0 % Extracorporeal membrane oxygenation Control No significant difference in death at 60 days (35% vs. 46%; RR 0.76, 95% CI 0.55 to 1.04) Secondary outcomes Significant decrease in treatment failure at 60 days (35% vs. 58%; RR 0.62, 95% CI 0.47 to 0.82) Borderline significant increase in days free of RRT (50 days vs. 32 days; AD 18 days, 95% CI 0 to 51) No significant difference in days free from mechanical ventilation (23 days vs. 3 days; AD 20 days, 95% CI -5 to 32) Safety outcomes No significant differences in hemorrhagic stroke, pneumothorax, ventilator-associated pneumonia, massive bleeding. Significant differences in severe thrombocytopenia (27% vs. 16%), bleeding events leading to packed red-cell transfusion (46% vs. 28%), ischemic stroke (0% vs. 5%). Conclusion In patients with very severe ARDS, as indicated by one of three criteria - a ratio of partial pressure of arterial oxygen to the FiO2 < 50 mmHg for > 3 hours; a ratio of partial pressure of arterial oxygen to the FiO2 < 80 mmHg for > 6 hours; or an arterial blood pH < 7.25 with a partial pressure of arterial CO2 of at least 60 mmHg for > 6 hours, ECMO was not superior to control with respect to death at 60 days. Reference Alain Combes, David Hajage, Gilles Capellier et al. Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome. N Engl J Med. 2018 May 24;378(21):1965-1975. Open reference URL https://web.pathway.md/studies/reci6YNhAbxGHOxeP 2/2