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Multimodal Assessment of the Neurological Prognosis of Patients With Brain Lesions on ExtraCorporeal Life Support

Multimodal Assessment of the Neurological Prognosis of Patients With Brain Lesions on ExtraCorporeal Life Support

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03633981
Acronym
NeuroECMO
Enrollment
50
Registered
2018-08-16
Start date
2018-09-01
Completion date
2019-12-01
Last updated
2018-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain-injured Patients on Extracorporeal Life Support

Brief 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. 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).

Interventions

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

OTHERneurological assessment when a neurological event occurs

next neurological event: * seizures * pupillary asymmetry * myoclonias * brain stem reflex abnormalities * osteotendinous reflex abnormalities

OTHERmortality assessment

to 28 days

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with brain lesions on veno-arterial circulatory support after cardiac arrest or cardiogenic shock who require at least 24 hours of sedation

Exclusion criteria

* Extubation expected within the first 24 hours of management * Minor patient * Pregnant women

Design outcomes

Primary

MeasureTime frame
Early mortality assessment28 days

Countries

France

Contacts

Primary ContactMohamed Omar ELLOUZE
mohamedomar.ellouze@chu-dijon.fr+33 380293079

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026