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

Central Hospital, Nancy, France

Status: Not yet enrolling

Conditions: Transfusion Related Complication; Blood Cells Transfusion; Extracorporeal Membrane Oxygenation Complication

Treatments: Other: Transfusion rate of red blood cells

Study type: Observational

Funder types: Other

Identifiers

NCT05696210

2022PI060

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

110 participants in 2 patient groups

High transfusion rate group

Description:

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.

Treatment:

Other: Transfusion rate of red blood cells

Low transfusion rate group

Description:

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.