An interventional study of CT scan in Trauma, Brain, sponsored by University Hospital, Grenoble. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-28.
Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Prevention
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.
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:
1,775 studies on the registry are indexed under Brain Injuries, Traumatic; 449 are open to participants now.
This study's enrollment of 30 is below the median of 56 across 1,134 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
During this study each patient will have 3 CT scans : D0, D1 and D3. A daily follow up during first seven days in ICU, then a follow up at D28 if still in hospital, and a phone call at M6 for neurological outcome
Radiation: CT scan
3 ct scans : D0, D1 and D3
Clinical evolution during first 7 days in ICU with therapeutic intensity level (TILsum)
Composite 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.
Time frame: 7 days after TBI
Mortality according to scan profiles
Time frame: 28 days after TBI and 6 month after TBI
Morbidity (consequences of the trauma) according to scan profiles
Lenght of stay in ICU with more than 20 mmHg of intracranial pressure with no stimulation
Time frame: 28 days after TBI
Morbidity (consequences of the trauma) according to scan profiles
length of stay in ICU with a therapeutic intensity level \> or = 8,
Time frame: 28 days after TBI
Morbidity (consequences of the trauma) according to scan profiles
Hospital stay length
Time frame: 28 days after TBI
Morbidity (consequences of the trauma) according to scan profiles
ICU stay length days with mechanical ventilation
Time frame: 28 days after TBI
Morbidity (consequences of the trauma) according to scan profiles
Glasgow Outcome Scale (GOSe)
Time frame: 6 months after TBI
Comparison and Description of correlation between early scan profiles evolution signature by AI and to clinical evolution (with TILSum)
Analysis of main outcome (TIL sum after 7 days in ICU maximum) according to a kinetic scan evolution between D0, D1 and D3
Time frame: 7 days after TBI
Neurological Pupil Index
Measure of neurological pupilla index within 1h after admission and at D1
Time frame: 1 day after TBI
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble