A Phase 1 interventional study of Packed Red Blood Cells (PRBCs) in Cardiogenic Shock, Extracorporeal Membrane Oxygenation and Transfusion Related Complication, sponsored by University Hospital, Lille. Recruiting at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by University Hospital, Lille · Phase 1, Interventional, and Treatment
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
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.
Exclusion Criteria:
Patients will recieve red blood cells transfusion in case of a drop of ScVO2 \<65% after an assessment for the optimisation of SaO2 normalisation (SaO2\>94%), volume optimisation, ECMO output increase, Fever (body temperature 38°3 C°), Anxiety and Pain
Drug: Packed Red Blood Cells (PRBCs)
Transfusion will be performed in case of a hemoglobin drop \<9 g/dL
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.
Also known as: ScVO2 assesment to guide transfusion
Number of PRBCs transfused per VA-ECMO day of support
Total number of PRBCs transfused during support adjusted for VA- ECMO duration
Time frame: From randomisation until VA-ECMO weanning assessed up to 28 days
Number of PRBCs transfused per VA-ECMO day of support in postcardiotomy patients
Total number of PRBCs transfused during support adjusted for VA- ECMO duration in patients that underwent cardiac surgery
Time frame: From randomisation until VA-ECMO weanning assessed up to 28 days
Total number of PRBCs transfused during the 28-day following cannulation
Total number of PRBCs transfused during the 28-day following cannulation
Time frame: From randomisation until 28 days
Changes in hemoglobin levels during VA-ECMO support
daily hemoglobin levels
Time frame: From randomisation until VA-ECMO weanning assessed up to 28 days
Changes in ScVO2 levels during VA-ECMO support
daily ScVO2 levels
Time frame: From randomisation until VA-ECMO weanning assessed up to 28 days
Changes in vosoactive index score levels during VA-ECMO support
daily vasoactive index score levels
Time frame: From randomisation until VA-ECMO weanning assessed up to 28 days
Mortality under ECMO support
All cause mortality before ECMO weaning
Time frame: From randomisation until VA-ECMO weanning assessed up to 28 days
90-day Mortality
All cause mortality from cannulation untill 90 days
Time frame: 90 days from cannulation
ECMO removal modalities
Proportion of patients that according to each reason for removal ( Recovery, heart transplantation, Left ventricle or biventricle assist device or death under support)
Time frame: From randomisation until VA-ECMO weanning assessed up to 28 days
Duration of mechanical ventilation
Duration of mechnanical ventilation from cannulation untill 28 days
Time frame: 28 days from cannulation
Proportion of patient that received a renal replacement therapy and its duration
Number of patient that underwent a renal replacement therapy and duration of renal replacement therapy from cannulation untill 28 days
Time frame: 28 days from cannulation
Duration of vasoactive support
Duration of vasoactive drug support from cannulation untill 28 days
Time frame: 28 days from cannulation
Hospital lenght of stay
Length of stay from cannulation censored at 90 day
Time frame: 28 days from cannulation
HLA immuno-sensitisation
Proportion of HLA immunosensitisation occuring after cannulation
Time frame: 28 and 90 days from cannulation
Proportion of patient with Transfusion related immunologic ( non HLA-related) complications
Transfusion related acute lung injury, hemolytic anemia, irregular antibodies
Time frame: From randomisation until 28 days
Proportion of patients with nex onset of sepsis
Sepsis is defined according to Surviving Sepsis Campaign guideline
Time frame: From randomisation until 28 days
Proportion of patients with a new onset of acute kidney injury
Acute kidney injury is define according to KDIGO classification
Time frame: From randomisation until 28 days
Proportion of patients with liver failure
Liver failure is defined as Hepatic component of SOFA score, Transaminasis Levels
Time frame: From randomisation until 28 days
Ischemic stroke
Ischemic stroke is defined as clinical symptoms confirmed by aCT Scan of MRI imaging
Time frame: From randomisation until 28 days
Myocardial infarction
According to the Universal definition of myocardial infarction, ESC guidelines
Time frame: From randomisation until 28 days
Pulmonary oedema
Dignose by the attending physician based on (Dyspnae, Thoracic X-rays), bowel ischemia ( Abdominal CT or endoscopy proven)
Time frame: From randomisation until 28 days
Anaphylactic complications
Anaphylaxis defined according to Ring and Messer Classification
Time frame: From randomisation until 28 days
Bowel Ischemia
Proven by Abdominal CT or endoscopy
Time frame: From randomisation until 28 days
Cost effectiveness analysis
Actual costs at 28 and 90 days and modelisation for 5 years
Time frame: 28 days, 90 days and 5 years from randomisation
Plan to share: Undecided
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Lille