Ignite Creation Date:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2026-03-03 @ 1:09 PM
Study NCT ID:
NCT03659006
Status:
UNKNOWN
Last Update Posted:
2018-10-23
First Post:
2018-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of Predictive Neuroinflammatory Biomarkers of Neuro-radiological Evolution in Severe Traumatic Brain Injury
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Identification of Predictive Neuroinflammatory Biomarkers of Neuro-radiological Evolution in Severe Traumatic Brain Injury
Status:
UNKNOWN
Status Verified Date:
2018-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICON-TBI
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: