NCT03659006

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Severe Traumatic Brain Injury

Interventions

Type	Name	Description
BIOLOGICAL	Biological Collection	Blood sampling on catheter and CSF sampling from VDE, multimodal MRI at D42 and D365, Neurological and neuropsychological evaluation at one year

Timeline

• Start date: 2018-10-15
• Primary completion: 2020-07-30
• Completion: 2020-07-30
• First posted: 2018-09-06
• Last updated: 2018-10-23

Locations

1 site across 1 country: France