Individualized Or Conventional Transfusion Strategy During Veno-Arterial Extracorporeal Membrane Oxygenation Support (ICONE Study): Rationale and Design of a Prospective Multicenter Randomized Controlled Trial
Abstract
Background Red blood cell (RBC) transfusion practices during veno-arterial extracorporeal membrane oxygenation (VA-ECMO) are heterogeneous, and the benefit – harm balance remains uncertain. Current recommendations rely on predefined hemoglobin thresholds and do not provide criteria for individualized transfusion. As the primary goal of RBC transfusion is to optimize oxygen delivery (DO₂) to meet oxygen consumption (VO₂), a strategy guided by a surrogate of DO₂/VO₂ mismatch – central venous oxygen saturation (ScvO₂)— may be more appropriate than fixed liberal transfusion thresholds. Methods ICONE is a multicenter, randomized, controlled trial comparing two transfusion strategies in adult patients supported by VA-ECMO for refractory cardiogenic shock. Patients are randomized 1:1 and stratified according to postcardiotomy versus medical etiology to either individualized or conventional transfusion strategy. In the individualized group, transfusion is triggered by ScvO 2 <65% despite optimization of VO₂ determinants. In the conventional group, transfusion was triggered by hemoglobin <9 g/dL. The primary endpoint is the number of RBCs units transfused per day of ECMO support. Secondary outcomes include 28-day composite of major adverse outcomes (key secondary endpoint), 90-days all-cause mortality, rate of organ failure, transfusion-related immune and non-immune complications (including human leucocyte antigen allosensitization) and cost effectiveness. A total of 236 patients provides 80% power to detect a 25% reduction in the primary endpoint and in key secondary outcomes using a two-sided test at 0.05 significance level (considering hierarchical testing framework) and considering 5% drop out. The study was registered in April 2020 (NCT05699005; IDRCB 2021-A01925-36) and is currently recruiting. Conclusion The ICONE trial may contribute to changing transfusion practice in VA-ECMO.
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BibTeX
@article{moussa2026individualized,
title = {{Individualized Or Conventional Transfusion Strategy During Veno-Arterial Extracorporeal Membrane Oxygenation Support (ICONE Study): Rationale and Design of a Prospective Multicenter Randomized Controlled Trial}},
author = {Mouhamed Djahoum Moussa and Osama Abou Arab and Julien Labreuche and Emmanuel Besnier and Pierre-Gregoire Guinot and Fanette Denis and Benoit Dervaux and Yazine Mahjoub and Thibault Duburcq and Saad Nseir and Alain Duhamel and Francis Juthier and Emmanuel Robin and André Vincentelli},
journal = {American Heart Journal},
year = {2026},
month = sep,
doi = {10.1016/j.ahj.2026.107616},
url = {https://u-picardie.hal.science/hal-05770861v1},
note = {CC BY},
}
RIS
TY - JOUR
TI - Individualized Or Conventional Transfusion Strategy During Veno-Arterial Extracorporeal Membrane Oxygenation Support (ICONE Study): Rationale and Design of a Prospective Multicenter Randomized Controlled Trial
AU - Mouhamed Djahoum Moussa
AU - Osama Abou Arab
AU - Julien Labreuche
AU - Emmanuel Besnier
AU - Pierre-Gregoire Guinot
AU - Fanette Denis
AU - Benoit Dervaux
AU - Yazine Mahjoub
AU - Thibault Duburcq
AU - Saad Nseir
AU - Alain Duhamel
AU - Francis Juthier
AU - Emmanuel Robin
AU - André Vincentelli
PY - 2026
DA - 2026/09/30
JO - American Heart Journal
DO - 10.1016/j.ahj.2026.107616
UR - https://u-picardie.hal.science/hal-05770861v1
AB - Background Red blood cell (RBC) transfusion practices during veno-arterial extracorporeal membrane oxygenation (VA-ECMO) are heterogeneous, and the benefit – harm balance remains uncertain. Current recommendations rely on predefined hemoglobin thresholds and do not provide criteria for individualized transfusion. As the primary goal of RBC transfusion is to optimize oxygen delivery (DO₂) to meet oxygen consumption (VO₂), a strategy guided by a surrogate of DO₂/VO₂ mismatch – central venous oxygen saturation (ScvO₂)— may be more appropriate than fixed liberal transfusion thresholds. Methods ICONE is a multicenter, randomized, controlled trial comparing two transfusion strategies in adult patients supported by VA-ECMO for refractory cardiogenic shock. Patients are randomized 1:1 and stratified according to postcardiotomy versus medical etiology to either individualized or conventional transfusion strategy. In the individualized group, transfusion is triggered by ScvO 2 <65% despite optimization of VO₂ determinants. In the conventional group, transfusion was triggered by hemoglobin <9 g/dL. The primary endpoint is the number of RBCs units transfused per day of ECMO support. Secondary outcomes include 28-day composite of major adverse outcomes (key secondary endpoint), 90-days all-cause mortality, rate of organ failure, transfusion-related immune and non-immune complications (including human leucocyte antigen allosensitization) and cost effectiveness. A total of 236 patients provides 80% power to detect a 25% reduction in the primary endpoint and in key secondary outcomes using a two-sided test at 0.05 significance level (considering hierarchical testing framework) and considering 5% drop out. The study was registered in April 2020 (NCT05699005; IDRCB 2021-A01925-36) and is currently recruiting. Conclusion The ICONE trial may contribute to changing transfusion practice in VA-ECMO.
SN - 0002-8703
SN - 1097-6744
ER -