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

January 13, 2023 updated by: Klein Thomas, Central Hospital, Nancy, France
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year survival
Time Frame: 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
date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality rate during hospitalization for cardiogenic shock with the need for Veno-arterial extracorporeal membrane oxygenation
Time Frame: 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.
date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months
30-day mortality
Time Frame: 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
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.
Time Frame: 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.
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.
Time Frame: 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
date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 20, 2023

Primary Completion (Anticipated)

January 21, 2023

Study Completion (Anticipated)

March 30, 2023

Study Registration Dates

First Submitted

January 13, 2023

First Submitted That Met QC Criteria

January 13, 2023

First Posted (Actual)

January 25, 2023

Study Record Updates

Last Update Posted (Actual)

January 25, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022PI060

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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