Identification of Predictive Neuroinflammatory Biomarkers of Neuro-radiological Evolution in Severe Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Interleukin-1 level in blood predict changes in brain volume assessed by quantitative MRI.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Biological Collection
Blood sampling on catheter and CSF sampling from VDE, multimodal MRI at D42 and D365, Neurological and neuropsychological evaluation at one year
干预措施: Biological Collection (Biological)
结局指标
主要结局
Interleukin-1 level in blood predict changes in brain volume assessed by quantitative MRI.
时间窗: Day 42 and 12 months
Brain volume evolution assessed by quantitative MRI between Day 42 and Day 365
次要结局
- 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)(Blood and CSF samples collected at Day1, Day2, Day3, Day5 and Day7)