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Artificial Intelligence Analysis of Initial Scan Evolution of Traumatic Brain Injured Patient to Predict Neurological Outcome

Artificial Intelligence Analysis of Initial Scan Evolution of Traumatic Brain Injured Patient to Predict Neurological Outcome: Pilot Translational an Exploratory Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04058379
Acronym
RADIOMIC-TBI
Enrollment
30
Registered
2019-08-15
Start date
2020-01-01
Completion date
2021-10-12
Last updated
2021-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma, Brain

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.

Interventions

RADIATIONCT scan

3 ct scans : D0, D1 and D3

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical evolution during first 7 days in ICU with therapeutic intensity level (TILsum)7 days after TBIComposite criteria : Head position, depth, sort and objective of sedation, presence or absence of a CSF draining system, management of ventilation, presence or absence of a hyperosmolar therapy, management of body temperature, surgical intervention for intracranial hypertension.

Secondary

MeasureTime frameDescription
Neurological Pupil Index1 day after TBIMeasure of neurological pupilla index within 1h after admission and at D1
Comparison and Description of correlation between early scan profiles evolution signature by AI and to clinical evolution (with TILSum)7 days after TBIAnalysis of main outcome (TIL sum after 7 days in ICU maximum) according to a kinetic scan evolution between D0, D1 and D3
Mortality according to scan profiles28 days after TBI and 6 month after TBI
Morbidity (consequences of the trauma) according to scan profiles28 days after TBILenght of stay in ICU with more than 20 mmHg of intracranial pressure with no stimulation

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026