Table 1.
Secondary objectives | Secondary endpoints |
Mortality during hospitalisation and up to 180 days | All-cause mortality at 48 hours and at days 7, 60 and 180 |
VA-ECMO weaning time | VA-ECMO duration |
Adverse cardiovascular events | Composite endpoint of death, cardiac transplant, escalation to LVAD and stroke at days 30, 60 and 180 |
Necessity of fluid and vasopressor support | Cumulated amount of administered fluids and duration of vasopressor use in ICU |
Lactate clearance | Duration to normalisation of lactate |
Duration of organ failure | Number of days alive without organ failure(s), defined with the SOFA score and its components (respiratory, liver, coagulation and renal), between inclusion, D7 and D30 |
Mechanical ventilation support use | Duration of mechanical ventilation and the number of days between inclusion and days 30, 60 and 180, alive without mechanical ventilation |
Renal replacement therapy use | Number of days alive without renal replacement therapy and number of days between inclusion and days 30, 60 and 180, without renal replacement therapy |
Duration of ICU stay and total duration of hospitalisation | Duration of ICU stay and of hospitalisation |
Risk of bleeding | Number of severe and moderate bleeding complications estimated using the BARC classification15 and the number of packed red blood cells transfused under VA-ECMO |
Risk of sepsis | Infection probability: pulmonary, blood and VA-ECMO cannulae |
BARC, bleeding academic research consortium; ICU, intensive care unit; LVAD, left ventricul assist device; VA-ECMO, venoarterial extracorporeal membrane oxygenation.