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

NCT03633981 | Unknown

• 1 other identifier: ELLOUZE 2018 Neuro ECMO
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Brain-injured Patients on Extracorporeal Life Support

Outcome Measures

Primary Outcomes (1)

• Early mortality assessment

  28 days

Interventions

clinical examinations OTHER

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 occurs OTHER

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

mortality assessment OTHER

to 28 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

RECRUITING

MeSH Terms

Interventions

Restraint, Physical

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Mohamed Omar ELLOUZE

  Centre Hospitalier Universitaire Dijon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Omar ELLOUZE

CONTACT

+33 380293079; mohamedomar.ellouze@chu-dijon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 16, 2018
• Study Start: September 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 16, 2018

Record last verified: 2018-08

Locations

FR (1)