Clinical trial NCT05696210: Evaluation of the 1-year Prognosis of Patients Under Veno-arterial Extracorporeal Membrane Oxygenation for Cardiogenic Shock With Blood Transfusion Requirement
Official title: Evaluation of the 1-year Prognosis of Patients Under Veno-arterial Extracorporeal Membrane Oxygenation for Cardiogenic Shock With Blood Transfusion Requirement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Extracorporeal Membrane Oxygenation Complication
Blood Cells Transfusion
Transfusion Related Complication
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who were hospitalized between 2016 and 2021 for cardiogenic shock requiring Veno-arterial extracorporeal membrane oxygenation, outside the context of cardiac arrest, managed in the ICU.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 1-year survival
timeFrame: date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 1 year
Secondary outcomes:
measure: All-cause mortality rate during hospitalization for cardiogenic shock with the need for Veno-arterial extracorporeal membrane oxygenation
timeFrame: date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months
measure: 30-day mortality
timeFrame: date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 30 days
measure: Number of patients with stage 4 chronic kidney disease (GFR <30 mL/min) or with the need for chronic dialysis at 30 days.
timeFrame: date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 30 days
measure: Number of patients with stage 4 chronic kidney disease (GFR <30 mL/min) or with need for chronic dialysis at 1 year.
timeFrame: date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 1 year
Other outcomes:
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