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RECRUITING Phase 1 ClinicalTrials.gov

Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO

Sponsor: University Hospital, Lille • ClinicalTrials.gov ID: NCT05699005

Registry updated: 2026-09-17
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Description

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

Interventions

  • Packed Red Blood Cells (PRBCs) (Drug)
    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.

Eligibility criteria

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

Conditions

Cardiogenic Shock Extracorporeal Membrane Oxygenation Transfusion Related Complication Anemia Oxygen Delivery

Locations

  • Service d'Anesthésie-Réanimation CCV Hôpital Cardiologique Centre Hospitalier et Universitaire de Lille — Lille, NORD, France
  • CHU Amiens — Amiens, France
  • CHU Dijon — Dijon, France
  • Centre de Réanimation, Hôpital Salengro, CHU Lille — Lille, France
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record