Status:
UNKNOWN
Prediction for Coma Recovery With Comaweb
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Brain Injury, Coma
Cardiac Arrest (CA)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The general objective of the comaScore project is to provide an external validation of the accuracy of the comaScore, a score derived from magnetic resonance imaging (MRI), to predict 1 year outcome o...
Detailed Description
The general objective of the comaScore project is to provide an external validation of the accuracy of the comaScore, a score derived from magnetic resonance imaging (MRI), to predict 1 year outcome o...
Eligibility Criteria
Inclusion
- Patient Inclusion criteria
- Male or female subject of 18 years old or above
- Affiliated to a social security system excluding "Aide Médicale d'État (AME)"
- Hospitalized in an intensive care unit and requiring mechanical ventilation after TBI, aSAH or CA
- Absence of response to simple orders not explained by sedation alone at inclusion
- Patient within 7 to 45 days after onset of TBI, aSAH or CA
- Scheduled MRI within 5 days after inclusion
- Written informed consent to participate in the study must be obtained proxy/legal representative.
- Patient non-inclusion criteria
- MRI unavailability between day 7 and day 45 after brain injury
- Origin of coma other than CA, TBI or aSAH
- Pre-existing serious brain disease prior to coma status
- Contra-indication to perform MRI
- Subject protected by the law (curatorship or tutorship)
- Patient secondary exclusion criteria
- Consciousness recovery before MRI exam
- Contra-indication to perform MRI (appeared / discovered after inclusion)
- Healthy controls Inclusion criteria
- Male or female subject from 18 to 65 years
- Affiliated to a social security system excluding "Aide Médicale d'État (AME)".
- No history of previous brain disease
- No contra-indication to perform an MRI.
- No pregnancy
- Voluntarily agrees to participate by providing written informed consent
- Healthy controls Non-Inclusion criteria
- 1\. Subject protected by the law (curatorship or tutorship)"
Exclusion
Key Trial Info
Start Date :
January 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
611 Patients enrolled
Trial Details
Trial ID
NCT03874208
Start Date
January 15 2020
End Date
September 1 2022
Last Update
January 28 2020
Active Locations (1)
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1
Centre Hospitalier Saint-Jean
Perpignan, France, 66000