Clinical trial NCT04058379: Artificial Intelligence Analysis of Initial Scan Evolution of Traumatic Brain Injured Patient to Predict Neurological Outcome
Official title: Artificial Intelligence Analysis of Initial Scan Evolution of Traumatic Brain Injured Patient to Predict Neurological Outcome: Pilot Translational an Exploratory Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trauma, Brain
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2019-08-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: We assume that an early iterative automatic CT scan analysis (D0, D1 and D3) by different AI approaches will allow an early differentiation of the tissues evolution after TBI. Our objective is to couple theses scan profiles to a neurological evolution, measured by therapeutic intensity.

Detailed description: Traumatic brain injury is a common and serious pathology, responsible of an important morbi-mortality. The TBI can be consider as a complex set of nosological entities of different evolution with difficult early identification whereas the main issue of this pathology depends on prevention and management of the lesions caused by the initial cerebral aggression.

Different evolutionary profiles seems to exist and sometimes coexists: edema evolution, hemorrhagic transformation and/or cerebrospinal fluid (CSF) resorption issues with hydrocephalus apparition.

Currently, there is no Imaging methods that can be used in every day clinical management that allows a visualization, quantification and prediction of these different lesional evolutions

CT scan is the reference imaging method for TBI patient monitoring. It allows a lesion description, a therapeutic adaptation and an evaluation of the prognostic.

Even if it is used as a routine examination, the analysis of cerebral scanners remains manual and a non-quantitative one, which make a little informative analysis as far as lesions evolution is concerned.

Recently it has been established the automatic MRI analysis with AI approach allows:

1. - To show aspects of images that can't be seen to the naked eye
2. - To automatically segment and quantify the different tissues (edema, hemorrhage...). First tests on this kind of analysis on CT scans shows that this technology can be transferred from MRI to CT scans and more importantly it brings out new quantitative informations on cerebral lesions evolution.

Eligibility criteria: Inclusion Criteria:

* Age \> or = 18 years old
* Closed TBI
* Primary admission in Grenoble University Hospital
* Initial CT scan with visible cerebral lesion rated at least 3 on abbreviated injury score (AIS)
* In ICU for an expected length of 48 hours
* Social security system affiliation

Exclusion Criteria:

* Life expectation \<48 hours
* In ICU for more than 24h
* Transferred from another hospital
* Patients corresponding to articles L1121-5, L1121-6, L1121-7, L1121-8 (under legal protection) of French Public Health Code
* Patient in exclusion time of another study

Primary outcomes:
measure: Clinical evolution during first 7 days in ICU with therapeutic intensity level (TILsum)
timeFrame: 7 days after TBI
Secondary outcomes:
measure: Mortality according to scan profiles
timeFrame: 28 days after TBI and 6 month after TBI
measure: Morbidity (consequences of the trauma) according to scan profiles
timeFrame: 28 days after TBI
measure: Morbidity (consequences of the trauma) according to scan profiles
timeFrame: 28 days after TBI
measure: Morbidity (consequences of the trauma) according to scan profiles
timeFrame: 28 days after TBI
measure: Morbidity (consequences of the trauma) according to scan profiles
timeFrame: 28 days after TBI
measure: Morbidity (consequences of the trauma) according to scan profiles
timeFrame: 6 months after TBI
measure: Comparison and Description of correlation between early scan profiles evolution signature by AI and to clinical evolution (with TILSum)
timeFrame: 7 days after TBI
measure: Neurological Pupil Index
timeFrame: 1 day after TBI
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Pierre BOUZAT
role: PRINCIPAL_INVESTIGATOR
References: