TY - JOUR
T1 - Reduced anticoagulation targets in extracorporeal life support (RATE)
T2 - study protocol for a randomized controlled trial
AU - van Minnen, Olivier
AU - Oude Lansink-Hartgring, Annemieke
AU - van den Boogaard, Bas
AU - van den Brule, Judith
AU - Bulpa, Pierre
AU - Bunge, Jeroen J.H.
AU - Delnoij, Thijs S.R.
AU - Elzo Kraemer, Carlos V.
AU - Kuijpers, Marijn
AU - Lambermont, Bernard
AU - Maas, Jacinta J.
AU - de Metz, Jesse
AU - Michaux, Isabelle
AU - van de Pol, Ineke
AU - van de Poll, Marcel
AU - Raasveld, S. Jorinde
AU - Raes, Matthias
AU - dos Reis Miranda, Dinis
AU - Scholten, Erik
AU - Simonet, Olivier
AU - Taccone, Fabio S.
AU - Vallot, Frederic
AU - Vlaar, Alexander P.J.
AU - van den Bergh, Walter M.
N1 - Funding Information:
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.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/5/16
Y1 - 2022/5/16
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85130645125&partnerID=8YFLogxK
U2 - 10.1186/s13063-022-06367-w
DO - 10.1186/s13063-022-06367-w
M3 - Article
C2 - 35578271
AN - SCOPUS:85130645125
SN - 1745-6215
VL - 23
JO - Trials
JF - Trials
IS - 1
M1 - 405
ER -