RecruitingPhase 1NCT05699005

Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO

Comparison of an Individualized Transfusion Strategy to a Conventional Strategy in Patients Undergoing Peripheral Veno-arterial ECMO for Refractory Cardiogenic Shock: a Randomized Controlled Trial - ICONE

Sponsor

University Hospital, Lille

Enrollment

236 participants

Start Date

Sep 18, 2023

Study Type

INTERVENTIONAL

Conditions

Oxygen Delivery Cardiogenic Shock Anemia Extracorporeal Membrane Oxygenation Transfusion Related Complication

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

Min Age: 18 Years

Inclusion Criteria5

Age of 18 and older,
supported by peripheral VA-ECMO
for cardiogenic shock
Life expentency >90 days
Central venous line available ScVO2 measurement

Exclusion Criteria7

Pregnancy,
Lack of health insurance,
Opposition to blood transfusion,
Known congenital hemoglobin disease or disorder,
Metabolic alcaloosis with pH>7.8,
eCPR,
Legally incapacitated adults

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Interventions

DRUGPacked 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.