Brain-injured Patients on Extracorporeal Life SupportNeuroECMONCT03633981
Multimodal Assessment of the Neurological Prognosis of Patients With Brain Lesions on ExtraCorporeal Life Support
An observational study of Brain-injured Patients on Extracorporeal Life Support, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
It seems of the greatest importance to evaluate the neurological prognosis of patients with brain lesions after cardiorespiratory arrest or circulatory failure requiring circulatory assistance. However, to date, there is no clinical or paraclinical diagnostic test to reliably assess the future of these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain-injured Patients on Extracorporeal Life Support
- What is being tested?
- clinical examinations, neurological assessment when a neurological event occurs and mortality assessment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2018to 1 Dec 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with brain lesions on veno-arterial ECLS after cardiac arrest or cardiogenic shock, requiring at least 24 hours sedation
Who may be able to join
- Patients with brain lesions on veno-arterial circulatory support after cardiac arrest or cardiogenic shock who require at least 24 hours of sedation
Who cannot join
- Extubation expected within the first 24 hours of management
- Minor patient
- Pregnant women
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourogne
Dijon, 21000
Mohamed Omar ELLOUZE, +33 380293079, mohamedomar.ellouze@chu-dijon.fr
About this study
It seems of the greatest importance to evaluate the neurological prognosis of patients with brain lesions after cardiorespiratory arrest or circulatory failure requiring circulatory assistance.
However, to date, there is no clinical or paraclinical diagnostic test to reliably assess the future of these patients.
The objective of this study is to highlight the clinical and imaging factors for establishing a neurological prognosis in patients at risk of brain lesions under ExtraCorporeal Life Support (ECLS).
- Being tested
- clinical examinations, neurological assessment when a neurological event occurs, mortality assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical examinationsOther
Collection of data from the following tests at H0 (as soon as the ECLS is put in place), H12 (within 12 hours following stabilisation of the dynamic state), H24 and every day until complete neurological recovery:
- right and left pupillometry (3 times)
- BIS values
- right and left NIRS values
- right and left transcranial Doppler
- neurological clinical examination
neurological assessment when a neurological event occursOther
next neurological event:
- seizures
- pupillary asymmetry
- myoclonias
- brain stem reflex abnormalities
- osteotendinous reflex abnormalities
mortality assessmentOther
to 28 days
What is being measured
The primary outcome is the main question the study is designed to answer.
Early mortality assessment
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start1 Sep 2018
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain-injured Patients on Extracorporeal Life SupportStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Omar ELLOUZE, Principal investigator, Centre Hospitalier Universitaire Dijon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633981
- Sponsor's protocol ID
- ELLOUZE 2018 Neuro ECMO
- Acronym
- NeuroECMO
- Status last verified
- Aug 2018
- First submitted
- 14 Aug 2018
- Last updated
- 16 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Assessment of the Neurological Prognosis of Patients With Brain Lesions on ExtraCorporeal Life Support
- ClinicalTrials.gov ID
- NCT03633981
- Acronym / sponsor ID
- NeuroECMO / ELLOUZE 2018 Neuro ECMO
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 16 Aug 2018 (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.
It seems of the greatest importance to evaluate the neurological prognosis of patients with brain lesions after cardiorespiratory arrest or circulatory failure requiring circulatory assistance.
However, to date, there is no clinical or paraclinical diagnostic test to reliably assess the future of these patients.
The objective of this study is to highlight the clinical and imaging factors for establishing a neurological prognosis in patients at risk of brain lesions under ExtraCorporeal Life Support (ECLS).
Study design
- Observational model
- Cohort
- 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 with brain lesions on veno-arterial ECLS after cardiac arrest or cardiogenic shock, requiring at least 24 hours sedation
Key inclusion criteria (1 listed)
- Patients with brain lesions on veno-arterial circulatory support after cardiac arrest or cardiogenic shock who require at least 24 hours of sedation
Key exclusion criteria (3 listed)
- Extubation expected within the first 24 hours of management
- Minor patient
- Pregnant women
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 |
|---|---|---|
| clinical examinationsCollection of data from the following tests at H0 (as soon as the ECLS is put in place), H12 (within 12 hours following stabilisation of the dynamic state), H24 and every day until complete neurological recovery: * right and left pupillometry (3 times) * BIS values * right and left NIRS values * right and left transcranial Doppler * neurological clinical examination | Other | – |
| neurological assessment when a neurological event occursnext neurological event: * seizures * pupillary asymmetry * myoclonias * brain stem reflex abnormalities * osteotendinous reflex abnormalities | Other | – |
| mortality assessmentto 28 days | Other | – |
Primary outcome
Early mortality assessment
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
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.
Mohamed Omar ELLOUZE principal investigator
Centre Hospitalier Universitaire Dijon
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 Brain-injured Patients on Extracorporeal Life Support, run by Centre Hospitalier Universitaire Dijon 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 1 inclusion and 3 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 16 Oct 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Omar ELLOUZE (+33 380293079, mohamedomar.ellouze@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early mortality assessment (time frame: 28 days). 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 16 Oct 2018.