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Trial record 10 of 316 for:    Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

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

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ClinicalTrials.gov Identifier: NCT03659006
Recruitment Status : Not yet recruiting
First Posted : September 6, 2018
Last Update Posted : September 6, 2018
Sponsor:
Collaborators:
Robert Debré Hospital
University of Cambridge
Mario Negri Institute for Pharmacological Research
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Severe Traumatic Brain Injury Biological: Biological Collection Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Identification of Predictive Neuroinflammatory Biomarkers of Neuro-radiological Evolution in Severe Traumatic Brain Injury
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Biological Collection
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
Blood sampling on catheter and CSF sampling from VDE, multimodal MRI at D42 and D365, Neurological and neuropsychological evaluation at one year




Primary Outcome Measures :
  1. Interleukin-1 level in blood predict changes in brain volume assessed by quantitative MRI. [ Time Frame: Day 42 and 12 months ]
    Brain volume evolution assessed by quantitative MRI between Day 42 and Day 365


Secondary Outcome Measures :
  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) [ Time Frame: Blood and CSF samples collected at Day1, Day2, Day3, Day5 and Day7 ]
    Plasma and Serum biological collection, multimodal MRI database, clinical database



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03659006


Contacts
Contact: Vincent Degos, PU-PH 01 42 16 37 61 vincent.degos@aphp.fr
Contact: Gregory Torkomian, Master 01 42 16 37 01 gregory.torkomian@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Robert Debré Hospital
University of Cambridge
Mario Negri Institute for Pharmacological Research
Investigators
Principal Investigator: Vincent Degos, PU-PH Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03659006     History of Changes
Other Study ID Numbers: K171201J
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
inflammatory Biomarkers, Traumatic brain injury, multimodal MRI, tertiary lesion

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System