Clinical trial NCT05699005: Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cardiogenic Shock
Extracorporeal Membrane Oxygenation
Transfusion Related Complication
Anemia
Oxygen Delivery
Keywords: ECMO
ECLS
Refractory cardiogenic shock
Transfusion
ScVO2
Outcome
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Amiens University Hospital
name: University Hospital, Caen
name: University Hospital, Rouen
name: Centre Hospitalier Universitaire Dijon
name: Centre hospitalier de Dunkerque
name: Centre Hospitalier de Lens
First posted: 2023-01-26
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of PRBCs transfused per VA-ECMO day of support
timeFrame: From randomisation until VA-ECMO weanning assessed up to 28 days
Secondary outcomes:
measure: Number of PRBCs transfused per VA-ECMO day of support in postcardiotomy patients
timeFrame: From randomisation until VA-ECMO weanning assessed up to 28 days
measure: Total number of PRBCs transfused during the 28-day following cannulation
timeFrame: From randomisation until 28 days
measure: Changes in hemoglobin levels during VA-ECMO support
timeFrame: From randomisation until VA-ECMO weanning assessed up to 28 days
measure: Changes in ScVO2 levels during VA-ECMO support
timeFrame: From randomisation until VA-ECMO weanning assessed up to 28 days
measure: Changes in vosoactive index score levels during VA-ECMO support
timeFrame: From randomisation until VA-ECMO weanning assessed up to 28 days
measure: Mortality under ECMO support
timeFrame: From randomisation until VA-ECMO weanning assessed up to 28 days
measure: 90-day Mortality
timeFrame: 90 days from cannulation
measure: ECMO removal modalities
timeFrame: From randomisation until VA-ECMO weanning assessed up to 28 days
measure: Duration of mechanical ventilation
timeFrame: 28 days from cannulation
measure: Proportion of patient that received a renal replacement therapy and its duration
timeFrame: 28 days from cannulation
measure: Duration of vasoactive support
timeFrame: 28 days from cannulation
measure: Hospital lenght of stay
timeFrame: 28 days from cannulation
measure: HLA immuno-sensitisation
timeFrame: 28 and 90 days from cannulation
measure: Proportion of patient with Transfusion related immunologic ( non HLA-related) complications
timeFrame: From randomisation until 28 days
measure: Proportion of patients with nex onset of sepsis
timeFrame: From randomisation until 28 days
measure: Proportion of patients with a new onset of acute kidney injury
timeFrame: From randomisation until 28 days
measure: Proportion of patients with liver failure
timeFrame: From randomisation until 28 days
measure: Ischemic stroke
timeFrame: From randomisation until 28 days
measure: Myocardial infarction
timeFrame: From randomisation until 28 days
measure: Pulmonary oedema
timeFrame: From randomisation until 28 days
measure: Anaphylactic complications
timeFrame: From randomisation until 28 days
measure: Bowel Ischemia
timeFrame: From randomisation until 28 days
measure: Cost effectiveness analysis
timeFrame: 28 days, 90 days and 5 years from randomisation
Other outcomes:
Locations:
city: Lille
country: France
facility: Service d'Anesthésie-Réanimation CCV Hôpital Cardiologique Centre Hospitalier et Universitaire de Lille
state: Nord
Study officials:
affiliation: University Hospital, Lille
name: Mouhamed MOUSSA, MD
role: PRINCIPAL_INVESTIGATOR
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