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Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO

ConditionsCardiogenic ShockExtracorporeal Membrane OxygenationTransfusion Related ComplicationAnemiaOxygen Delivery
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Lille

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age of 18 and older,

supported by peripheral VA-ECMO

for cardiogenic shock

Life expentency >90 days

Disqualifiers

Pregnancy,

Lack of health insurance,

Opposition to blood transfusion,

Known congenital hemoglobin disease or disorder,

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

236 Participants
are divided into 2 treatment groups
Group A: Individulised transfusion strategy groupExperimental treatment 1 intervention
Group B: Conventionnal transfusion strategy groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

Changes in hemoglobin levels during VA-ECMO support

daily hemoglobin levels

Time frame
From randomisation until VA-ECMO weanning assessed up to 28 days
4

Changes in ScVO2 levels during VA-ECMO support

daily ScVO2 levels

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

Other outcomes

Sponsors and contacts

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University Hospital, Lille

Lead sponsor

Amiens University Hospital

Collaborator

University Hospital, Caen

Collaborator

University Hospital, Rouen

Collaborator

Centre Hospitalier Universitaire Dijon

Collaborator

Centre Hospitalier de Lens

Collaborator

Source ClinicalTrials.gov
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