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NCT Number: NCT05699005

Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Service d'Anesthésie-Réanimation CCV Hôpital Cardiologique Centre Hospitalier et Universitaire de Lille

Lille, NORD, 59000, France

Location status: Recruiting

Location contact

Julien Tabareau

CONTACT

[email protected]

0320445962

Mouhamed D Moussa, MD

CONTACT

[email protected]

=33659248780

About this study

Peripheral VA-ECMO is the mainstay of mechanical circulatory support in refractory cardiogenic shock. This treatment is associated with a high consumption of packed red blood cells (PRBCs), which can reach 1 to 3 units of PRBCs per day of support. The main reasons for such a high consumption of PRBCs are the very frequent hemorrhagic complications and the prevalence of anemias not directly related to the hemorrhagic episodes. These anemias are frequent during VA-ECMO support owing to hemolysis, hemodilution, previous bleeding episodes, thrombosis, etc.

In order to restore, maintain, or increase oxygen delivery (DO2) to peripheral organs, RGCs are often performed when anemia is observed. Several studies have reported an association between transfusion of these PRBCs with morbidity and mortality in this ECMO setting.

There is no appropriate strategy to reduce PRBC consumption, taking into account other determinants of DO2. In addition, there is currently no validated or consensus hemoglobin threshold to guide transfusion in this specific population. Furthermore, this predefined threshold-based approach may be inappropriate in the setting of VA-ECMO due to differences in DO2 requirements between patients based on their etiology, disease severity, and ECMO modality. In addition, large variations in DO2 can be observed in the same patient and between ECMO settings. Therefore, a more individualized strategy guided by a DO2 surrogate, ScVO2, may be more appropriate in this population. This ScVO2 approach has recently been shown to be associated with reduced PRBCs in two randomized controlled trials in cardiac surgery patients.

The objective of this multicenter randomized controlled trial is to compare two red cell transfusion strategies in patients receiving extracorporeal veno-arterial membrane oxygenation for refractory cardiogenic shock.

An individualized transfusion strategy based on ScVO2 level is compared with a conventional strategy based on a predefined hemoglobin threshold. The primary endpoint is red blood cell consumption, the secondary endpoints are subgroup analysis, mortality, morbidity, and cost-effectiveness.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: ScVO2 assesment to guide transfusion

Primary outcomes

  1. Number of PRBCs transfused per VA-ECMO day of support

    Time frame: From randomisation until VA-ECMO weanning assessed up to 28 days

    Total number of PRBCs transfused during support adjusted for VA- ECMO duration

Secondary outcomes

  1. Number of PRBCs transfused per VA-ECMO day of support in postcardiotomy patients

    Time frame: From randomisation until VA-ECMO weanning assessed up to 28 days

    Total number of PRBCs transfused during support adjusted for VA- ECMO duration in patients that underwent cardiac surgery

  2. Total number of PRBCs transfused during the 28-day following cannulation

    Time frame: From randomisation until 28 days

    Total number of PRBCs transfused during the 28-day following cannulation

  3. Changes in hemoglobin levels during VA-ECMO support

    Time frame: From randomisation until VA-ECMO weanning assessed up to 28 days

    daily hemoglobin levels

  4. Changes in ScVO2 levels during VA-ECMO support

    Time frame: From randomisation until VA-ECMO weanning assessed up to 28 days

    daily ScVO2 levels

  5. Changes in vosoactive index score levels during VA-ECMO support

    Time frame: From randomisation until VA-ECMO weanning assessed up to 28 days

    daily vasoactive index score levels

  6. Mortality under ECMO support

    Time frame: From randomisation until VA-ECMO weanning assessed up to 28 days

    All cause mortality before ECMO weaning

  7. 90-day Mortality

    Time frame: 90 days from cannulation

    All cause mortality from cannulation untill 90 days

  8. ECMO removal modalities

    Time frame: From randomisation until VA-ECMO weanning assessed up to 28 days

    Proportion of patients that according to each reason for removal ( Recovery, heart transplantation, Left ventricle or biventricle assist device or death under support)

  9. Duration of mechanical ventilation

    Time frame: 28 days from cannulation

    Duration of mechnanical ventilation from cannulation untill 28 days

  10. Proportion of patient that received a renal replacement therapy and its duration

    Time frame: 28 days from cannulation

    Number of patient that underwent a renal replacement therapy and duration of renal replacement therapy from cannulation untill 28 days

  11. Duration of vasoactive support

    Time frame: 28 days from cannulation

    Duration of vasoactive drug support from cannulation untill 28 days

  12. Hospital lenght of stay

    Time frame: 28 days from cannulation

    Length of stay from cannulation censored at 90 day

  13. HLA immuno-sensitisation

    Time frame: 28 and 90 days from cannulation

    Proportion of HLA immunosensitisation occuring after cannulation

  14. Proportion of patient with Transfusion related immunologic ( non HLA-related) complications

    Time frame: From randomisation until 28 days

    Transfusion related acute lung injury, hemolytic anemia, irregular antibodies

  15. Proportion of patients with nex onset of sepsis

    Time frame: From randomisation until 28 days

    Sepsis is defined according to Surviving Sepsis Campaign guideline

  16. Proportion of patients with a new onset of acute kidney injury

    Time frame: From randomisation until 28 days

    Acute kidney injury is define according to KDIGO classification

  17. Proportion of patients with liver failure

    Time frame: From randomisation until 28 days

    Liver failure is defined as Hepatic component of SOFA score, Transaminasis Levels

  18. Ischemic stroke

    Time frame: From randomisation until 28 days

    Ischemic stroke is defined as clinical symptoms confirmed by aCT Scan of MRI imaging

  19. Myocardial infarction

    Time frame: From randomisation until 28 days

    According to the Universal definition of myocardial infarction, ESC guidelines

  20. Pulmonary oedema

    Time frame: From randomisation until 28 days

    Dignose by the attending physician based on (Dyspnae, Thoracic X-rays), bowel ischemia ( Abdominal CT or endoscopy proven)

  21. Anaphylactic complications

    Time frame: From randomisation until 28 days

    Anaphylaxis defined according to Ring and Messer Classification

  22. Bowel Ischemia

    Time frame: From randomisation until 28 days

    Proven by Abdominal CT or endoscopy

  23. Cost effectiveness analysis

    Time frame: 28 days, 90 days and 5 years from randomisation

    Actual costs at 28 and 90 days and modelisation for 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Mouhamed MOUSSA, MD

CONTACT

[email protected]

0320445962

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Amiens University Hospital
  • Centre Hospitalier Universitaire Dijon
  • Centre Hospitalier de Lens
  • University Hospital, Caen
  • University Hospital, Rouen

Registry information

Official study title

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

Acronym: ICONE

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jan 26, 2023
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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