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A Study of Biomarkers of Mild Traumatic BRAIN Injury (BRAINI)

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ClinicalTrials.gov Identifier: NCT04032509
Recruitment Status : Not yet recruiting
First Posted : July 25, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:
Patients with mild traumatic brain injury (mTBI) represent a burden of patients admitted to the emergency department. According to the guidelines, a cerebral CT scan is indicated after mTBI according to the specific conditions. However, variability exists regarding the respect of these CT scan indications, and less than 10% of patients will have visible brain lesions on CT scan. Recently, serum Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) biomarkers have shown ability to differentiate normal and abnormal CT scan findings after mTBI. These encouraging results prompted us to launch a prospective study using automated and quick measurements of GFAP and UCH-L1 biomarkers to validate these findings.

Condition or disease Intervention/treatment
Mild Traumatic Brain Injury Other: 2 x 5 mL blood sample

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Study Type : Observational
Estimated Enrollment : 1600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Clinical Study of Biomarkers of Mild Traumatic BRAIN Injury
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Mild TBI
Mild TBI (GCS 13-15 on admission) within 12 hours after injury
Other: 2 x 5 mL blood sample
2 x 5 mL blood sample to determine the performance of the automated VIDAS BTI platform in assessing serum concentrations of GFAP and UCH-L1 to rule out the need for a CT-scan after mTBI.




Primary Outcome Measures :
  1. Performance of the VIDAS-BTI assay in terms of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and their corresponding lower limit of 95% confidence interval by comparison with brain CT scan findings. [ Time Frame: 12 hours post Traumatic Brain Injury (TBI) ]
    2 x 5mL blood sample


Secondary Outcome Measures :
  1. Determination of the added value of the two biomarkers measurements to Transcranial Doppler (TCD) performed on admission to detect patients at risk of neurological worsening and patients allowed for a safe return home [ Time Frame: Admission ]
    TCD measures at admission

  2. Determination of the added value of the two biomarkers measurements to Transcranial Doppler (TCD) performed on admission to detect patients at risk of neurological worsening and patients allowed for a safe return home [ Time Frame: 7 days after traumatic brain injury (TBI) ]
    Neurological status at 1 week after TBI

  3. Determination of the added value of the two biomarkers measurements to Transcranial Doppler (TCD) performed on admission to detect patients at risk of neurological worsening and patients allowed for a safe return home [ Time Frame: 7 days after traumatic brain injury (TBI) ]
    Quality of life after brain injury (QOLIBRI) Questionnaire

  4. Determination the potential of the two biomarkers in predicting neurological outcome [ Time Frame: 3 month after TBI ]
    Extended Glasgow Outcome Scale (GOSE)

  5. Determination of the potential of the two biomarkers in predicting neurological outcome [ Time Frame: 3 month after TBI ]
    Quality of life after brain injury (QOLIBRI) Questionnaire)

  6. Determination of the potential of the two biomarkers in predicting neurological outcome [ Time Frame: 3 month after TBI ]
    EuroQuol 5 dimensions 5 level questionnaire (EQ-5D-5L)

  7. Determination of the potential of the two biomarkers in predicting neurological outcome [ Time Frame: 3 month after TBI ]
    Rivermead Post-concussion symptoms Questionnaire (RPQ)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
1600 patients: 1300 patients in France and 300 patients in Spain
Criteria

Inclusion Criteria:

  • Patients >18 years old (France)
  • Mild TBI (GCS 13-15 on admission) within 12 hours after injury
  • Indication of brain CT scan:

    • neurological focal deficit
    • anterograde amnesia
    • Glasgow coma scale score <15 after 2 hours post-TBI
    • suspicion of vault depression fracture
    • fracture of the basal skull
    • persisting nausea, vomiting or headache
    • post-TBI seizures
    • Pre-injury treatment with antithrombotic drugs
    • Loss of consciousness or amnesia with age >65 years, fall >1m or hit pedestrian
    • Other condition requiring CT scan according to the in-charge physician.

Exclusion Criteria:

  • GCS 3-12 on admission
  • Time of injury unknown
  • Time to injury exceeding 12 hours
  • Primary admission for non-traumatic neurological disorder (e.g., stroke, spontaneous intracranial hematoma)
  • Penetrating head trauma
  • Patient with mechanical ventilation
  • Pre-injury neurological disorder affecting the assessment of neurological outcome: dementia, Parkinson's disease, multiple sclerosis, seizure disorder, brain tumor, and history of neurosurgery, stroke or transient ischemic attack (TIA) within the last 30 days
  • Venipuncture not feasible
  • No realization of brain CT-scan
  • Subject under judiciary control
  • Pregnant or breastfeeding woman
  • Subject in exclusion period of another study

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): NCT04032509


Contacts
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Contact: Jean françois PAYEN, Pr 04 76 76 92 88 JFPayen@chu-grenoble.fr
Contact: Marion RICHARD 04 76 76 68 29 MRichard7@chu-grenoble.fr

Locations
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France
CHU Bordeaux Not yet recruiting
Bordeaux, France
Contact: Cédric GIL JARDINE, Dr       cedric.giljardine@gmail.com   
Principal Investigator: Cédric GIL JARDINE, Dr         
CHU Dijon Not yet recruiting
Dijon, France
Contact: Patrick RAY, Pr       patrick.ray@chu-dijon.fr   
Principal Investigator: Patrick RAY, Pr         
CHU Grenoble Alpes Not yet recruiting
Grenoble, France
Contact: Maxime MAIGNAN, Dr    04 76 76 93 93    MMaignan@chu-grenoble.fr   
Principal Investigator: Maxime MAIGNAN, Dr         
Hopital Edouard HERRIOT - HCL Not yet recruiting
Lyon, France
Contact: Laurent JACQUIN, Dr       laurent.jacquin@chu-lyon.fr   
Principal Investigator: Laurent JACQUIN, Dr         
Hopital Lyon Sud HCL Not yet recruiting
Lyon, France
Contact: Marion DOUPLAT, Dr       Marion.douplat@chu-lyon.fr   
Principal Investigator: Marion DOUPLAT, DR         
CHU Montpellier Not yet recruiting
Montpellier, France
Contact: Mustapha SEBBANE, P       m-sebbane@chu-montpellier.fr   
Principal Investigator: Mustapha SEBBANE, Pr         
CHU Nantes Not yet recruiting
Nantes, France
Contact: Emmanuel MONTASSIER, Dr       Emmanuel.MONTASSIER@chu-nantes.fr   
Principal Investigator: Emmanuel MONTASSIER, Dr         
CHU Poitiers Not yet recruiting
Poitiers, France
Contact: Jérémy GUENEZAN, Dr       jeremyguenezan@gmail.com   
Principal Investigator: Jérémy GUENEZAN, Dr         
CHU Tours Not yet recruiting
Tours, France
Contact: Said LARIBI, Pr       S.LARIBI@chu-tours.fr   
Principal Investigator: Said LARIBI, Pr         
Spain
Hospital Universitario de 12 Octubre Not yet recruiting
Madrid, Spain
Contact: Alfonso LAGARES, Dr       alfonso.lagares@salud.madrid.org   
Principal Investigator: Alfonso LAGARES, Dr         
Sponsors and Collaborators
University Hospital, Grenoble

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT04032509     History of Changes
Other Study ID Numbers: 38RC19.176
2019-A01525-52 ( Other Identifier: ID RCB )
First Posted: July 25, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Wounds and Injuries
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating
Central Nervous System Diseases
Nervous System Diseases