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

NCT ID: NCT05696210

Last Updated: 2023-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-20

Study Completion Date

2023-03-30

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.

Conditions

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Extracorporeal Membrane Oxygenation Complication Blood Cells Transfusion Transfusion Related Complication

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Transfusion rate of red blood cells

Intervention Type OTHER

Transfusion rate of red blood cells greater than 7

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.

No interventions assigned to this group

Interventions

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Transfusion rate of red blood cells

Transfusion rate of red blood cells greater than 7

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Klein Thomas

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 40171953 (View on PubMed)

Other Identifiers

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2022PI060

Identifier Type: -

Identifier Source: org_study_id

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