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Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO

Study acronym: ICONE
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial sites expanded: 1 → 4 locations
    • Eligibility criteria expanded, about 12 words
    • Publications: details revised at 16 of 17 entries
  2. Primary completion pushed from Sep 18, 2026 to Mar 18, 2028
    • Study completion pushed from Dec 18, 2026 to Dec 18, 2028
    v4
  3. Primary completion date: Sep 18, 2025 to Sep 18, 2026
    • Enrollment target: 238 to 236
    • Study completion date: Dec 18, 2025 to Dec 18, 2026
    • Collaborators: 6 to 5
    v3
  4. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Jan 1, 2025 to Sep 18, 2025
    • Start date changed from estimate of Feb 2023 to Sep 18, 2023
    • Study completion date: Jan 1, 2025 to Dec 18, 2025
    • Site details revised
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT05699005
Lead Sponsor University Hospital, Lille
Collaborators: Amiens University Hospital, University Hospital, Caen, University Hospital, Rouen, Centre Hospitalier Universitaire Dijon, Centre Hospitalier de Lens
Conditions
(from sponsor)		 Cardiogenic Shock, Extracorporeal Membrane Oxygenation, Transfusion Related Complication, Anemia, Oxygen Delivery
Related terms Anemia, Shock, Cardiogenic
Enrollment 236 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov