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. 2019 Oct 14;9(10):e031697. doi: 10.1136/bmjopen-2019-031697

Table 1.

Secondary objectives and endpoints

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.