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

NCT ID: NCT03633981

Last Updated: 2018-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-12-01

Brief Summary

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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).

Detailed Description

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Conditions

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Brain-injured Patients on Extracorporeal Life Support

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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clinical examinations

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

Intervention Type OTHER

neurological assessment when a neurological event occurs

next neurological event:

* seizures
* pupillary asymmetry
* myoclonias
* brain stem reflex abnormalities
* osteotendinous reflex abnormalities

Intervention Type OTHER

mortality assessment

to 28 days

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohamed Omar ELLOUZE

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Dijon

Locations

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Chu Dijon Bourogne

Dijon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Mohamed Omar ELLOUZE

Role: CONTACT

+33 380293079

Facility Contacts

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Mohamed Omar ELLOUZE

Role: primary

+33 380293079

Other Identifiers

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ELLOUZE 2018 Neuro ECMO

Identifier Type: -

Identifier Source: org_study_id

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