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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05696210
Acronym
HemoECMO
Enrollment
110
Registered
2023-01-25
Start date
2023-01-20
Completion date
2023-03-30
Last updated
2023-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERTransfusion rate of red blood cells

Transfusion rate of red blood cells greater than 7

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years

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

Design outcomes

Primary

MeasureTime frameDescription
1-year survivaldate of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 1 yearTo 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

Secondary

MeasureTime frameDescription
All-cause mortality rate during hospitalization for cardiogenic shock with the need for Veno-arterial extracorporeal membrane oxygenationdate of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 monthsAssess the association between transfusion strategy as assessed by hemoglobin nadir during hospitalization with all-cause mortality.
30-day mortalitydate of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 30 daysTo 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
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 daysAssess 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.
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 yearEvaluate 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026