Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO

Condition(s) studied

Investigational drug(s) / intervention(s)

Packed Red Blood Cells (PRBCs): Patient will recieve PRBCs transfusion only in case of ScVO2 level\<65% after assessment of patient for optimisation of SaO2 targeting 100%, volume status, ECMO flow (increase to 20% in relevant), pain, anxiety and fever (body temperature \>38°3). In both groups transfusion may be performed in case massive bleeding according to local protocols, STEMI, Hyperlactatemia \>4 that can be related to oxygen demand and supply DO2/VO2 ratio impairement, in all groups, transfusion should be performed in case of hemolobin level \<7g/dL or worsening of neurological condition (Increase in Neurological SOFA component of 1 and more) related to DO2/VO2 impairement.

Study summary

This multicenter randomized controlled trial compare two transfusion strategies of red blood cells transfusion in patients supported by veno-arterial extracorporeal membrane oxygenation for refractory cardiogenic shock.

An individualized transfusion strategy based on ScVO2 level, is compared to a conventionnal strategy based on predefined hemoglobin threshold. The primary endpoint is the consumption of packed red blod cells, secondary endpoints are subgroup analysis, mortality, morbidity, and cost-effectiveness

Eligibility

Primary outcome measure(s)

• Number of PRBCs transfused per VA-ECMO day of support — From randomisation until VA-ECMO weanning assessed up to 28 days
  Total number of PRBCs transfused during support adjusted for VA- ECMO duration

Trial sites (4)

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