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

Extracorporeal Membrane Oxygenation Complication Clinical Trial

— HemoECMO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05696210
• Other study ID #: 2022PI060
• Status: Not yet recruiting
• Start date: January 20, 2023
• Est. completion date: March 30, 2023

Study information

• Verified date: January 2023
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: March 30, 2023
• Est. primary completion date: January 21, 2023
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Extracorporeal Membrane Oxygenation Complication
• Shock, Cardiogenic
• Transfusion Related Complication

Intervention

Other:
• Transfusion rate of red blood cells
Transfusion rate of red blood cells greater than 7

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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