Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO
- Conditions
- Cardiogenic ShockExtracorporeal Membrane OxygenationTransfusion Related ComplicationAnemiaOxygen Delivery
- Interventions
- Drug: Packed Red Blood Cells (PRBCs)
- Registration Number
- NCT05699005
- Lead Sponsor
- University Hospital, Lille
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 238
- Age of 18 and older,
- supported by peripheral VA-ECMO
- for cardiogenic shock
- Life expentency >90 days
- Central venous line available ScVO2 measurement
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Individulised transfusion strategy group Packed Red Blood Cells (PRBCs) 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 Conventionnal transfusion strategy group Packed Red Blood Cells (PRBCs) Transfusion will be performed in case of a hemoglobin drop \<9 g/dL
- Primary Outcome Measures
Name Time Method Number of PRBCs transfused per VA-ECMO day of support From randomisation until VA-ECMO weanning assessed up to 28 days Total number of PRBCs transfused during support adjusted for VA- ECMO duration
- Secondary Outcome Measures
Name Time Method Number of PRBCs transfused per VA-ECMO day of support in postcardiotomy patients 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
Total number of PRBCs transfused during the 28-day following cannulation From randomisation until 28 days Total number of PRBCs transfused during the 28-day following cannulation
Changes in hemoglobin levels during VA-ECMO support From randomisation until VA-ECMO weanning assessed up to 28 days daily hemoglobin levels
Changes in ScVO2 levels during VA-ECMO support From randomisation until VA-ECMO weanning assessed up to 28 days daily ScVO2 levels
Mortality under ECMO support From randomisation until VA-ECMO weanning assessed up to 28 days All cause mortality before ECMO weaning
Hospital lenght of stay 28 days from cannulation Length of stay from cannulation censored at 90 day
Proportion of patient with Transfusion related immunologic ( non HLA-related) complications From randomisation until 28 days Transfusion related acute lung injury, hemolytic anemia, irregular antibodies
Changes in vosoactive index score levels during VA-ECMO support From randomisation until VA-ECMO weanning assessed up to 28 days daily vasoactive index score levels
Proportion of patients with nex onset of sepsis From randomisation until 28 days Sepsis is defined according to Surviving Sepsis Campaign guideline
HLA immuno-sensitisation 28 and 90 days from cannulation Proportion of HLA immunosensitisation occuring after cannulation
90-day Mortality 90 days from cannulation All cause mortality from cannulation untill 90 days
Proportion of patient that received a renal replacement therapy and its duration 28 days from cannulation Number of patient that underwent a renal replacement therapy and duration of renal replacement therapy from cannulation untill 28 days
Duration of vasoactive support 28 days from cannulation Duration of vasoactive drug support from cannulation untill 28 days
ECMO removal modalities 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)
Duration of mechanical ventilation 28 days from cannulation Duration of mechnanical ventilation from cannulation untill 28 days
Proportion of patients with a new onset of acute kidney injury From randomisation until 28 days Acute kidney injury is define according to KDIGO classification
Proportion of patients with liver failure From randomisation until 28 days Liver failure is defined as Hepatic component of SOFA score, Transaminasis Levels
Ischemic stroke From randomisation until 28 days Ischemic stroke is defined as clinical symptoms confirmed by aCT Scan of MRI imaging
Myocardial infarction From randomisation until 28 days According to the Universal definition of myocardial infarction, ESC guidelines
Pulmonary oedema From randomisation until 28 days Dignose by the attending physician based on (Dyspnae, Thoracic X-rays), bowel ischemia ( Abdominal CT or endoscopy proven)
Anaphylactic complications From randomisation until 28 days Anaphylaxis defined according to Ring and Messer Classification
Bowel Ischemia From randomisation until 28 days Proven by Abdominal CT or endoscopy
Cost effectiveness analysis 28 days, 90 days and 5 years from randomisation Actual costs at 28 and 90 days and modelisation for 5 years
Trial Locations
- Locations (1)
Service d'Anesthésie-Réanimation CCV Hôpital Cardiologique Centre Hospitalier et Universitaire de Lille
🇫🇷Lille, Nord, France