Identification of Predictive Neuroinflammatory Biomarkers of Neuro-radiological Evolution in Severe Traumatic Brain Injury

Study Overview
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Brief Summary
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Tertiary lesions responsible of the neurological decline after severe traumatic brain injury (TBI) are partially due to a persistent neuro-inflammation directly modulated by inflammatory mediators during the acute phase and detectable by using both multimodal MRI imaging and biological biomarkers during the acute phase after traumatic brain injury. The main objective is to identify if the level of IL-1beta in cerebrospinal fluid predict in a reliable and reproducible way, the neuro-radiological evolution evaluated by the comparison of a quantitative MRI performed in post-resuscitation and at one year (quantitative ΔIRM) in traumatic brain injuried patients. The secondary objectives are: To understand the links between the acute and chronic neuro-inflammatory phase in a population of TBI, To explore the contribution of the adaptive immune response in the persistent activation of the immune response, To Examine the links between persistent neuroinflammation, clinical deterioration and neuroimaging, To establish a correlation between the pathology and the physio-pathology of TBI.

Official Title
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Identification of Predictive Neuroinflammatory Biomarkers of Neuro-radiological Evolution in Severe Traumatic Brain Injury

Conditions
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Severe Traumatic Brain Injury

Intervention / Treatment
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* Biological: Biological Collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient ≥ 18 years old at the time of inclusion Written and informed consent obtained from the family / proxy Patient hospitalized in neuro-ICU following severe TBI with GCS ≤ 8 at admission Intubated / ventilated patient scheduled for external ventricular bypass within 24 hours of hospitalization Absence of contraindications to perform an MRI Patient affiliated to a social security scheme (free State medical aid excluded) Exclusion Criteria: Patient under protection of the law (guardianship or tutorship) TBI of ballistic origin Pregnant woman Pre-existing cerebral disease that can bias the MRI scan evaluation Contraindications to the MRI (pace maker, medical device incompatible with MRI, metal plates, ...) Patient with severe impairment of vital and / or life-threatening function with disability prior TBI Neurological antecedent susceptible to interfere with clinical evolution at one year Severe cardiogenic shock Severe respiratory impairment Extra-brain injuries involving immediate life-threatening Hemoglobin level below 9g / dL

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biological Collection<br>Blood sampling on catheter and CSF sampling from VDE, multimodal MRI at D42 and D365, Neurological and neuropsychological evaluation at one year | Biological: Biological Collection<br>* Blood sampling on catheter and CSF sampling from VDE, multimodal MRI at D42 and D365, Neurological and neuropsychological evaluation at one year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin-1 level in blood predict changes in brain volume assessed by quantitative MRI. | Brain volume evolution assessed by quantitative MRI between Day 42 and Day 365 | Day 42 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentrations of biomarkers such as Tau protein and beta-amyloid plaques in serum and cerebrospinal fluid (Aβ1-42, T-tau, and P-tau181P and Interleukin 1) | Plasma and Serum biological collection, multimodal MRI database, clinical database | Blood and CSF samples collected at Day1, Day2, Day3, Day5 and Day7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inflammatory Biomarkers, Traumatic brain injury, multimodal MRI, tertiary lesion