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Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO

NCT05699005 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2026-05-15

No results posted yet for this 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

Conditions

  • Cardiogenic Shock
  • Extracorporeal Membrane Oxygenation
  • Transfusion Related Complication
  • Anemia
  • Oxygen Delivery

Interventions

DRUG

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.

Sponsors & Collaborators

  • Amiens University Hospital

    collaborator OTHER

  • University Hospital, Caen

    collaborator OTHER

  • University Hospital, Rouen

    collaborator OTHER

  • Centre Hospitalier Universitaire Dijon

    collaborator OTHER

  • Centre Hospitalier de Lens

    collaborator OTHER

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Mouhamed MOUSSA, MD · University Hospital, Lille

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-18
Primary Completion
2026-09-18
Completion
2026-12-18

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05699005 on ClinicalTrials.gov