MortalityECMOCARDNCT05155904
Outcomes of Veno Arterial ECMO
An observational study of Mortality and Extra Corporeal Membrane Oxygenation, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
veno arterial (VA) extra corporeal membrane oxygenation (ECMO) is a rescue therapy with various indications including refractory cardiac arrest and refractory cardiogenic shock. Amiens hospital university has an ECMO program and is a regional center to address patients requiring VA ECMO. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mortality, Extra Corporeal Membrane Oxygenation
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 16 Nov 2021to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted in Amiens hospital university beneficing of a veno arterial (VA) extra corporeal membrane oxygenation (ECMO).
Who may be able to join
- age : ≥ 18
- Patient with a VA ECMO
Who cannot join
- age<18
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens Picardie
Amiens
Osama ABOU ARAB, abouarab.osama@chu-amiens.fr
About this study
Official title: In-hospital Mortality of Patients With Veno Arterial ECMO: a Prospective Observational Study
veno arterial (VA) extra corporeal membrane oxygenation (ECMO) is a rescue therapy with various indications including refractory cardiac arrest and refractory cardiogenic shock. Amiens hospital university has an ECMO program and is a regional center to address patients requiring VA ECMO. In spite of the application of international guidelines, the mortality of patients with VA remains high with an admitted survival rate at hospital discharge at 40%.
- Conditions
- Mortality, Extra Corporeal Membrane Oxygenation
- Keywords
- veno arterial, mortality, extra corporeal membrane oxygenation
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
In-hospital mortality of patients with : veno arterial (VA) extra corporeal membrane oxygenation (ECMO)
Measured: Up to hospital discharge, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start16 Nov 2021
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MortalityStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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 only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155904
- Sponsor's protocol ID
- PI2021_843_204
- Acronym
- ECMOCARD
- Status last verified
- Feb 2023
- First submitted
- 16 Nov 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-hospital Mortality of Patients With Veno Arterial ECMO: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05155904
- Acronym / sponsor ID
- ECMOCARD / PI2021_843_204
- Conditions
- Mortality, Extra Corporeal Membrane Oxygenation
- Keywords
- veno arterial, mortality, extra corporeal membrane oxygenation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 14 Dec 2021 (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.
veno arterial (VA) extra corporeal membrane oxygenation (ECMO) is a rescue therapy with various indications including refractory cardiac arrest and refractory cardiogenic shock. Amiens hospital university has an ECMO program and is a regional center to address patients requiring VA ECMO. In spite of the application of international guidelines, the mortality of patients with VA remains high with an admitted survival rate at hospital discharge at 40%.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted in Amiens hospital university beneficing of a veno arterial (VA) extra corporeal membrane oxygenation (ECMO).
Key inclusion criteria (2 listed)
- age : ≥ 18
- Patient with a VA ECMO
Key exclusion criteria (1 listed)
- age<18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In-hospital mortality
Time frame: Up to hospital discharge, an average of 1 month
In-hospital mortality of patients with : veno arterial (VA) extra corporeal membrane oxygenation (ECMO)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mortality and Extra Corporeal Membrane Oxygenation, run by Centre Hospitalier Universitaire, Amiens at 1 site in 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Osama Abou Arab, MD (03 22 08 78 36, abouarab.osama@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: Up to hospital discharge, an average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2023.