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Identification of Predictive Neuroinflammatory Biomarkers of Neuro-radiological Evolution in Severe Traumatic Brain Injury (ICON-TBI)

Primary Purpose

Severe Traumatic Brain Injury

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Biological Collection

About this trial

This is an interventional prevention trial for Severe Traumatic Brain Injury focused on measuring inflammatory Biomarkers, Traumatic brain injury, multimodal MRI, tertiary lesion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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

Sites / Locations

Anesthesy department - Hôpital Pitié SalpêtrièreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biological Collection

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Plasma and Serum biological collection, multimodal MRI database, clinical database

Full Information

NCT ID

NCT03659006

First Posted

July 9, 2018

Last Updated

October 22, 2018

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Hopital Universitaire Robert-Debre, University of Cambridge, Mario Negri Institute for Pharmacological Research

1. Study Identification

Unique Protocol Identification Number

NCT03659006

Brief Title

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

Acronym

ICON-TBI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

October 15, 2018 (Actual)

Primary Completion Date

July 30, 2020 (Anticipated)

Study Completion Date

July 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Hopital Universitaire Robert-Debre, University of Cambridge, Mario Negri Institute for Pharmacological Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Severe Traumatic Brain Injury

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Biological Collection

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Biological Collection

Intervention Description

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

Primary Outcome Measure Information:

Title

Interleukin-1 level in blood predict changes in brain volume assessed by quantitative MRI.

Description

Brain volume evolution assessed by quantitative MRI between Day 42 and Day 365

Time Frame

Day 42 and 12 months

Secondary Outcome Measure Information:

Title

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)

Description

Plasma and Serum biological collection, multimodal MRI database, clinical database

Time Frame

Blood and CSF samples collected at Day1, Day2, Day3, Day5 and Day7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Vincent Degos, PU-PH

Phone

01 42 16 37 61

vincent.degos@aphp.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Gregory Torkomian, Master

Phone

01 42 16 37 01

gregory.torkomian@aphp.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vincent Degos, PU-PH

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Anesthesy department - Hôpital Pitié Salpêtrière

City

Paris

ZIP/Postal Code

75013

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

DEGOS Vincent, MD

Phone

0142163761

vincent.degos@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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