Olivier van Minnen, Annemieke Oude Lansink-Hartgring, Bas van den Boogaard, Judith van den Brule, Pierre Bulpa, Jeroen J. H. Bunge, Thijs S. R. Delnoij, Carlos V. Elzo Kraemer, Marijn Kuijpers, Bernard Lambermont, Jacinta J. Maas, Jesse de Metz, Isabelle Michaux, Ineke van de Pol, Marcel van de Poll, S. Jorinde Raasveld, Matthias Raes, Dinis dos Reis Miranda, Erik Scholten, Olivier Simonet, Fabio S. Taccone, Frederic Vallot, Alexander P. J. Vlaar, Walter M. van den Bergh, Critical care, Anesthesiology, Peri-operative and Emergency medicine (CAPE), UCL - SSS/IREC/MEDA - Pôle de médecine aiguë, UCL - (MGD) Services des soins intensifs, Graduate School, Intensive Care Medicine, ACS - Amsterdam Cardiovascular Sciences, ACS - Microcirculation, AII - Inflammatory diseases, ACS - Pulmonary hypertension & thrombosis, MUMC+: MA Med Staf Spec Cardiologie (9), MUMC+: MA Medische Staf IC (9), RS: Carim - V04 Surgical intervention, Intensive Care, MUMC+: MA Heelkunde (9), and RS: NUTRIM - R2 - Liver and digestive health
Background Although life-saving in selected patients, ECMO treatment still has high mortality which for a large part is due to treatment-related complications. A feared complication is ischemic stroke for which heparin is routinely administered for which the dosage is usually guided by activated partial thromboplastin time (aPTT). However, there is no relation between aPTT and the rare occurrence of ischemic stroke (1.2%), but there is a relation with the much more frequent occurrence of bleeding complications (55%) and blood transfusion. Both are strongly related to outcome. Methods We will conduct a three-arm non-inferiority randomized controlled trial, in adult patients treated with ECMO. Participants will be randomized between heparin administration with a target of 2–2.5 times baseline aPTT, 1.5–2 times baseline aPTT, or low molecular weight heparin guided by weight and renal function. Apart from anticoagulation targets, treatment will be according to standard care. The primary outcome parameter is a combined endpoint consisting of major bleeding including hemorrhagic stroke, severe thromboembolic complications including ischemic stroke, and mortality at 6 months. Discussion We hypothesize that with lower anticoagulation targets or anticoagulation with LMWH during ECMO therapy, patients will have fewer hemorrhagic complications without an increase in thromboembolic complication or a negative effect on their outcome. If our hypothesis is confirmed, this study could lead to a change in anticoagulation protocols and a better outcome for patients treated with ECMO. Trial registration ClinicalTrials.gov NCT04536272. Registered on 2 September 2020. Netherlands Trial Register NL7969