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

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05696210
Collaborator
(none)
110
2.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Transfusion rate of red blood cells

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
110 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Evaluation of the 1-year Prognosis of Patients Under Veno-arterial Extracorporeal Membrane Oxygenation for Cardiogenic Shock With Blood Transfusion Requirement
Anticipated Study Start Date :
Jan 20, 2023
Anticipated Primary Completion Date :
Jan 21, 2023
Anticipated Study Completion Date :
Mar 30, 2023

Arms and Interventions

Arm Intervention/Treatment
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
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.

Outcome Measures

Primary Outcome Measures

  1. 1-year survival [date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 1 year]

    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

Secondary Outcome Measures

  1. 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]

    Assess the association between transfusion strategy as assessed by hemoglobin nadir during hospitalization with all-cause mortality.

  2. 30-day mortality [date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 30 days]

    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

  3. 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]

    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.

  4. 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]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Klein Thomas, Medical Doctor, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT05696210
Other Study ID Numbers:
  • 2022PI060
First Posted:
Jan 25, 2023
Last Update Posted:
Jan 25, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 25, 2023