[en] [en] 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.
Disciplines :
Anesthesia & intensive care
Author, co-author :
van Minnen, Olivier ; Department of Critical Care, University Medical Center Groningen, Room R3.904, PO BOX 30001, 9700, RB, Groningen, The Netherlands. o.van.minnen@umcg.nl
Oude Lansink-Hartgring, Annemieke; Department of Critical Care, University Medical Center Groningen, Room R3.904, PO BOX 30001, 9700, RB, Groningen, The Netherlands
van den Boogaard, Bas; Department of Intensive Care, OLVG, Amsterdam, The Netherlands
van den Brule, Judith; Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands
Bulpa, Pierre; Department of Intensive Care, CHU UCL Namur site Mont-Godinne, Yvoir, Belgium
Bunge, Jeroen J H; Department of Intensive Care Medicine, Erasmus Medical Center, Rotterdam, The Netherlands
Delnoij, Thijs S R; Department of Intensive Care Medicine, Maastricht University Medical Center, Maastricht, The Netherlands
Elzo Kraemer, Carlos V; Department of Intensive Care Medicine, Leiden University Medical Center, Leiden, The Netherlands
Kuijpers, Marijn; Department of Intensive Care Medicine, Isala Clinics, Zwolle, The Netherlands
Lambermont, Bernard ; Centre Hospitalier Universitaire de Liège - CHU > > Service des soins intensifs
Maas, Jacinta J; Department of Intensive Care Medicine, Leiden University Medical Center, Leiden, The Netherlands
de Metz, Jesse; Department of Intensive Care, OLVG, Amsterdam, The Netherlands
Michaux, Isabelle; Department of Intensive Care, CHU UCL Namur site Mont-Godinne, Yvoir, Belgium
van de Pol, Ineke; Department of Intensive Care Medicine, St. Antonius Hospital, Nieuwegein, The Netherlands
van de Poll, Marcel; Department of Intensive Care Medicine, Maastricht University Medical Center, Maastricht, The Netherlands
Raasveld, S Jorinde; Department of Intensive Care Medicine, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands
Raes, Matthias; Department of Intensive Care, University Hospital Brussels, Brussels, Belgium
Dos Reis Miranda, Dinis; Department of Intensive Care Medicine, Erasmus Medical Center, Rotterdam, The Netherlands
Scholten, Erik; Department of Intensive Care Medicine, St. Antonius Hospital, Nieuwegein, The Netherlands
Simonet, Olivier; Department of Intensive Care, Centre Hospitalier de Wallonie Picarde (CHwapi), Tournai, Belgium
Taccone, Fabio S; Department of Intensive Care, Hôpital Erasme Bruxelles, Brussels, Belgium
Vallot, Frederic; Department of Intensive Care, Centre Hospitalier de Wallonie Picarde (CHwapi), Tournai, Belgium
Vlaar, Alexander P J; Department of Intensive Care Medicine, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands
van den Bergh, Walter M; Department of Critical Care, University Medical Center Groningen, Room R3.904, PO BOX 30001, 9700, RB, Groningen, The Netherlands
ZonMw - Nederlandse Organisatie voor Gezondheidsonderzoek en Zorginnovatie [NL]
Funding text :
This trial is funded by ZonMw (project number: 848018014). The funder provided research funding but had no role in the design or execution of the trial.
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