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

NCT05696210 | Unknown

• 1 other identifier: 2022PI060
• Study Type: observational
• Target: 110
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• All-cause mortality rate during hospitalization for cardiogenic shock with the need for Veno-arterial extracorporeal membrane oxygenation

  date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months

• 30-day mortality

  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.

  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.

  date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 1 year

Study Arms (2)

High transfusion rate group

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

Low transfusion rate group

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.

Interventions

Transfusion rate of red blood cells OTHER

Transfusion rate of red blood cells greater than 7

High transfusion rate group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Related Publications (1)

• Brouland M, Kimmoun A, Delmas C, Duarte K, Girerd N, Vardon-Bounes F, Klein T. Association Between Red Blood Cells Transfusion and 1 Year Mortality in Patients on Venoarterial Extracorporeal Membrane Oxygenation for Cardiogenic Shock. ASAIO J. 2025 Oct 1;71(10):833-840. doi: 10.1097/MAT.0000000000002424. Epub 2025 Apr 2.

  PMID: 40171953 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 25, 2023
• Study Start: January 20, 2023
• Primary Completion: January 21, 2023
• Study Completion: March 30, 2023
• Last Updated: January 25, 2023

Record last verified: 2023-01