Evaluation of the 1-year Prognosis of Patients Under Veno-arterial Extracorporeal Membrane Oxygenation for Cardiogenic Shock With Blood Transfusion Requirement

Study Overview
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Brief Summary
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The primary objective of this work is to study the 1-year prognosis of patients who received Veno-arterial extracorporeal membrane oxygenation for cardiogenic shock with the need for blood transfusion. Secondary objectives are to determine whether the transfusion strategy used (liberal or restrictive) still has an impact on overall mortality. We will also determine the factors associated with overall in-hospital mortality and look at the impact of transfusion in relation to the risk of hemolysis on the consequences in the occurrence of long-term chronic renal failure.

Detailed Description
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The study of the prognostic impact of blood transfusion at 1 year in patients assisted by Veno-arterial extracorporeal membrane oxygenation in the context of cardiogenic shock would provide objective answers and optimize the decision to set up this assistance with regard to the possible long-term consequences. This decision currently remains at the discretion of the expert teams managing these patients. The inclusion of patients in a state of cardiogenic shock under Veno-arterial extracorporeal membrane oxygenation with the need for transfusion, will therefore allow the elaboration of a multicentric observational study interested in the prognosis at 1 year of patients under VA ECMO according to the adopted transfusion threshold.

Official Title
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Evaluation of the 1-year Prognosis of Patients Under Veno-arterial Extracorporeal Membrane Oxygenation for Cardiogenic Shock With Blood Transfusion Requirement

Conditions
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Extracorporeal Membrane Oxygenation Complication, Blood Cells Transfusion, Transfusion Related Complication

Intervention / Treatment
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* Other: Transfusion rate of red blood cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient of legal age (> 18 years) at the time of data collection. Hospitalization in intensive care unit Cardiogenic shock of medical or surgical etiology according to the SCAI definition (stage B to E) Need for cardio-circulatory assistance such as Veno-arterial extracorporeal membrane oxygenation for at least 24 hours Exclusion Criteria: - Age < 18 years In-hospital and out-of-hospital cardiac arrest. Veno-arterial extracorporeal membrane oxygenation set up at a center other than the study centers. Veno-arterial extracorporeal membrane oxygenation set up for less than 24 hours Death within 24 hours

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High transfusion rate group<br>patients requiring Veno-arterial extracorporeal membrane oxygenation for medical or post cardiotomy cardiogenic shock and with a blood transfusion rate greater than or equal to 7 red blood cells. | Other: Transfusion rate of red blood cells<br>* Transfusion rate of red blood cells greater than 7<br>|
| Low transfusion rate group<br>patients who required Veno-arterial extracorporeal membrane oxygenation for medical or post cardiotomy cardiogenic shock and with a blood transfusion rate strictly below 7 red blood cells. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year survival | To evaluate the association of blood transfusion (and its volume of administration) with the 1-year prognosis of patients managed with Veno-arterial extracorporeal membrane oxygenation for medical or post cardiotomy cardiogenic shock | date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality rate during hospitalization for cardiogenic shock with the need for Veno-arterial extracorporeal membrane oxygenation | Assess the association between transfusion strategy as assessed by hemoglobin nadir during hospitalization with all-cause mortality. | date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months | 
| 30-day mortality | To evaluate the association of blood transfusion (and its volume of administration) with the 30-day prognosis of patients managed with Veno-arterial extracorporeal membrane oxygenation for medical or postcardiotomy cardiogenic shock | date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 30 days | 
| Number of patients with stage 4 chronic kidney disease (GFR <30 mL/min) or with the need for chronic dialysis at 30 days. | Assess the association of transfusion strategy with the occurrence of chronic renal failure (GFR <30 mL/min or with the need for chronic dialysis) at 30 days. | date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 30 days | 
| Number of patients with stage 4 chronic kidney disease (GFR <30 mL/min) or with need for chronic dialysis at 1 year. | Evaluate the association of transfusion strategy with the occurrence of chronic renal failure (GFR <30 mL/min or with the need for chronic dialysis) at 1 year | date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 1 year |