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

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ClinicalTrials.gov Identifier: NCT03633981
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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).


Condition or disease Intervention/treatment
Brain-injured Patients on Extracorporeal Life Support Other: clinical examinations Other: neurological assessment when a neurological event occurs Other: mortality assessment

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multimodal Assessment of the Neurological Prognosis of Patients With Brain Lesions on ExtraCorporeal Life Support
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup


Intervention Details:
  • Other: 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
  • Other: neurological assessment when a neurological event occurs

    next neurological event:

    • seizures
    • pupillary asymmetry
    • myoclonias
    • brain stem reflex abnormalities
    • osteotendinous reflex abnormalities
  • Other: mortality assessment
    to 28 days


Primary Outcome Measures :
  1. Early mortality assessment [ Time Frame: 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with brain lesions on veno-arterial ECLS after cardiac arrest or cardiogenic shock, requiring at least 24 hours sedation
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633981


Contacts
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Contact: Mohamed Omar ELLOUZE +33 380293079 mohamedomar.ellouze@chu-dijon.fr

Locations
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France
Chu Dijon Bourogne Recruiting
Dijon, France, 21000
Contact: Mohamed Omar ELLOUZE    +33 380293079    mohamedomar.ellouze@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
Investigators
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Principal Investigator: Mohamed Omar ELLOUZE CHU DIJON BOURGOGNE

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03633981     History of Changes
Other Study ID Numbers: ELLOUZE 2018 Neuro ECMO
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No