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

NCT03659006 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-10-23

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Hopital Universitaire Robert-Debre

    collaborator OTHER

  • University of Cambridge

    collaborator OTHER

  • Mario Negri Institute for Pharmacological Research

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Vincent Degos, PU-PH · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-15
Primary Completion
2020-07-30
Completion
2020-07-30

Countries

  • France

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03659006 on ClinicalTrials.gov