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

Severe Traumatic Brain Injury Clinical Trial

— ICON-TBI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03659006
• Other study ID #: K171201J
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: July 30, 2020

Study information

• Verified date: July 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Vincent Degos, PU-PH
• Phone: 01 42 16 37 61
• Email: vincent.degos[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. patient = 18 years old at the time of inclusion

2. Written and informed consent obtained from the family / proxy

3. Patient hospitalized in neuro-ICU following severe TBI with GCS = 8 at admission

4. Intubated / ventilated patient scheduled for external ventricular bypass within 24 hours of hospitalization

5. Absence of contraindications to perform an MRI

6. Patient affiliated to a social security scheme (free State medical aid excluded)

Exclusion Criteria:

1. Patient under protection of the law (guardianship or tutorship)

2. TBI of ballistic origin

3. Pregnant woman

4. Pre-existing cerebral disease that can bias the MRI scan evaluation

5. Contraindications to the MRI (pace maker, medical device incompatible with MRI, metal plates, ...)

6. Patient with severe impairment of vital and / or life-threatening function with disability prior TBI

7. Neurological antecedent susceptible to interfere with clinical evolution at one year

8. Severe cardiogenic shock

9. Severe respiratory impairment

10. Extra-brain injuries involving immediate life-threatening

11. Hemoglobin level below 9g / dL

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Severe Traumatic Brain Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
France	Anesthesy department - Hôpital Pitié Salpêtrière	Paris

Sponsors (4)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Mario Negri Institute for Pharmacological Research, Robert Debré Hospital, University of Cambridge

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Concentrations of biomarkers such as Tau protein and beta-amyloid plaques in serum and cerebrospinal fluid (Aß1-42, T-tau, and P-tau181P and Interleukin 1)	Plasma and Serum biological collection, multimodal MRI database, clinical database	Blood and CSF samples collected at Day1, Day2, Day3, Day5 and Day7