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

NCT03659006 | Unknown

• 1 other identifier: K171201J
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Traumatic Brain Injury

Keywords

inflammatory Biomarkers, Traumatic brain injury, multimodal MRI, tertiary lesion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Biological Collection

EXPERIMENTAL

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

Interventions

Biological Collection BIOLOGICAL

Blood sampling on catheter and CSF sampling from VDE, multimodal MRI at D42 and D365, Neurological and neuropsychological evaluation at one year

Biological Collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Hopital Universitaire Robert-Debre: collaborator
• University of Cambridge: collaborator
• Mario Negri Institute for Pharmacological Research: collaborator

Study Sites (1)

Anesthesy department - Hôpital Pitié Salpêtrière

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Vincent Degos, PU-PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent Degos, PU-PH

CONTACT

01 42 16 37 61; vincent.degos@aphp.fr

Gregory Torkomian, Master

CONTACT

01 42 16 37 01; gregory.torkomian@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: September 6, 2018
• Study Start: October 15, 2018
• Primary Completion: July 30, 2020
• Study Completion: July 30, 2020
• Last Updated: October 23, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)