Extracorporeal Membrane Oxygenation ComplicationHemoECMONCT05696210
Evaluation of the 1-year Prognosis of Patients Under Veno-arterial Extracorporeal Membrane Oxygenation for Cardiogenic Shock With Blood Transfusion Requirement
An observational study of Extracorporeal Membrane Oxygenation Complication and Blood Cells Transfusion, run by Central Hospital, Nancy, France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Extracorporeal Membrane Oxygenation Complication, Blood Cells Transfusion, Transfusion Related Complication
- What is being tested?
- Transfusion rate of red blood cells
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2023to 30 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- - 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
About this study
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.
Read the 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.
- Conditions
- Extracorporeal Membrane Oxygenation Complication, Blood Cells Transfusion, Transfusion Related Complication
- Being tested
- Transfusion rate of red blood cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transfusion rate of red blood cellsOther
Transfusion rate of red blood cells greater than 7
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Assess the association between transfusion strategy as assessed by hemoglobin nadir during hospitalization with all-cause mortality.
Measured: date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months
30-day mortality
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
Measured: 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.
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.
Measured: 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.
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
Measured: date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start20 Jan 2023 (estimated)
- Primary completion21 Jan 2023 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extracorporeal Membrane Oxygenation ComplicationStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klein Thomas, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696210
- Sponsor's protocol ID
- 2022PI060
- Acronym
- HemoECMO
- Status last verified
- Jan 2023
- First submitted
- 13 Jan 2023
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40171953
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the 1-year Prognosis of Patients Under Veno-arterial Extracorporeal Membrane Oxygenation for Cardiogenic Shock With Blood Transfusion Requirement
- ClinicalTrials.gov ID
- NCT05696210
- Acronym / sponsor ID
- HemoECMO / 2022PI060
- Conditions
- Extracorporeal Membrane Oxygenation Complication, Blood Cells Transfusion, Transfusion Related Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 20 Jan 2023 (estimated)
- Primary completion
- 21 Jan 2023 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High transfusion rate group | – | Other: Transfusion rate of red blood cellspatients 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. |
| 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transfusion rate of red blood cellsTransfusion rate of red blood cells greater than 7 | Other | High transfusion rate group |
Primary outcome
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
4 secondary outcomes
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Derived from this study: PubMed 40171953Brouland 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Extracorporeal Membrane Oxygenation Complication and Blood Cells Transfusion, run by Central Hospital, Nancy, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05696210, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.