UnknownNot Applicable

Prediction for Coma Recovery With Comaweb

France611 participantsStarted 2020-01-15

Plain-language 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 of patients unresponsive to simple orders after traumatic brain injury (TBI), aneurysmal subarachnoid hemorrhages (aSAH) and cardiac arrest (CA) in the day 7 - day 45 period post brain injury.

Who can participate

Age range18 Years

SexALL

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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.
✓. MRI unavailability between day 7 and day 45 after brain injury

Exclusion criteria

✕. Consciousness recovery before MRI exam
✕. Contra-indication to perform MRI (appeared / discovered after inclusion)
✕. 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.

What they're measuring

The unfavorable outcome

Timeframe: 1 year after the initial brain injury

Trial details

NCT IDNCT03874208

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03

Contact for this trial

Louis, MD

1 42 16 33 85 louis.puybasset@aphp.fr

View on ClinicalTrials.gov More Brain Injury, Coma trials