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Usefulness of Biomarkers in the Management of Mild Traumatic Brain Injury in Adults (Biotraumap) (Biotraumap)

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ClinicalTrials.gov Identifier: NCT04543162
Recruitment Status : Recruiting
First Posted : September 10, 2020
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:

The indication of cranial computed tomography (CCT) is difficult to define for patients with mild traumatic brain injury (mTBI). For mTBI patients with a medium risk of intracranial complications, CCT scans are indicated although 90% of them are normal.

The interest of the S100B protein has been widely demonstrated in the management of mTBI in adults. Its serum concentration (for blood sampling drawn less than 3 hours after trauma) can accurately predict a normal CCT scan for mTBI patients with a medium risk of intracranial complications. That's why, serum assay of the S100B protein is routinely used in the Emergency Department of Clermont-Ferrand University Hospital for the treatment of patients with mTBI.

The objective of the study is to optimize the management strategy for mTBI patients by blood testing of new brain biomarkers. These biomarkers are synthesized by brain cells and are released into the blood in case of intracranial lesions.


Condition or disease
Traumatic Brain Injury Intracranial Injury

Detailed Description:

Other biomarkers of brain damage, involved in the pathophysiology of head trauma, are also known. These are, for example, GFAP (Glial Fibrillary Acidic Protein), UCH-L1 (Ubiquitine Carboxy Terminal Hydrolase L1), NSE (Neurone Specific Enolase), Tau, SBDP (Spectrin Breakdown Products) or NFL (Neurofilament) protein. To date, the too limited number of studies doesn't enable the use of these biomarkers routinely. Therefore we will study the interest of these biomarkers in the management of adult patients' mTBI. We wish to set a collection of biological samples drawn from 1500 patients consulting for mTBI (with a medium risk of intracranial complications) at the Emergency Department of Clermont-Ferrand University Hospital, and requiring an assay of the S100B protein.

The study will take place over a period of 36 months at Clermont-Ferrand University Hospital. Patients cared for mTBI when they come to the Emergency Department will be recruited according to the inclusion criteria. In case of no opposition, when having their blood drawn, one more tube will be drawn per patient. Then, the obtained serum will be frozen at -80 ° C for the next assays of the cerebral biomarkers such as: GFAP, UCH-L1, NSE, Tau, SBDP, NFL, etc. A later 2-weeks' telephone call after the head trauma will be made by a member of the staff of the Department of Biochemistry and Molecular Genetics.

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Usefulness of Biomarkers in the Management of Mild Traumatic Brain Injury in Adults
Actual Study Start Date : October 2, 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


Group/Cohort
patients with Mild Traumatic Brain Injury
patients with Mild Traumatic Brain Injury



Primary Outcome Measures :
  1. Diagnostic value of cerebral biomarkers GFAP [ Time Frame: Day 0 ]
    Evaluate the diagnostic value of cerebral biomarkers GFAP (ng/L)

  2. Diagnostic value of cerebral biomarkers UCH-L1 [ Time Frame: Day 0 ]
    Evaluate the diagnostic value of cerebral biomarkers UCH-L1 (ng/L)

  3. Diagnostic value of cerebral biomarkers NSE [ Time Frame: Day 0 ]
    Evaluate the diagnostic value of cerebral biomarkers NSE (µg/L)

  4. Diagnostic value of cerebral biomarkers Tau [ Time Frame: Day 0 ]
    Evaluate the diagnostic value of cerebral biomarkers TAU (ng/L)

  5. Diagnostic value of cerebral biomarkers SBDP [ Time Frame: Day 0 ]
    Evaluate the diagnostic value of cerebral biomarkers SBDP (µg/L)

  6. Diagnostic value of cerebral biomarkers NFL [ Time Frame: Day 0 ]
    Evaluate the diagnostic value of cerebral biomarkers NFL (ng/L)


Secondary Outcome Measures :
  1. Utility of serum biomarker measurement with respect to reduction of the cost of management [ Time Frame: Day 0 ]
    Calculate this cost reduction compared to the cost of a cerebral tomodensitometry

  2. Risk factors (antiplatelet agent) on biomarker results [ Time Frame: Day 0 ]
    Collect information from medical records and assess the impact on biomarker results from statistical tests

  3. risk factors (loss of consciousness) on biomarker results [ Time Frame: Day 0 ]
    Collect information from medical records and assess the impact on biomarker results from statistical tests

  4. risk factors (amnesia) on biomarker results [ Time Frame: Day 0 ]
    Collect information from medical records and assess the impact on biomarker results from statistical tests


Biospecimen Retention:   Samples Without DNA
Collection of additional blood volume (approximately 7 mL) during blood tests provided as part of the usual medical care in emergencies


Information from the National Library of Medicine

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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:   Non-Probability Sample
Study Population
Patients with mild Traumatic Brain Injury
Criteria

Inclusion Criteria:

  • Male and female patient, major
  • Patient admitted to the Emergency Department for mTBI, with a medium risk of intracranial lesions according to the SFMU (French Emergency Medicine Society) criteria, for which an S100B protein assay is indicated:
  • GCS score of 15 with at least one associated risk factor: amnesia facts more than 30 minutes before the mTBI loss of consciousness, anti platelet aggregating agent
  • Time between mTBI and blood draw (for the S100B protein assay) less than 3 hours.
  • Patient covered by a Social Security scheme.

Exclusion Criteria:

  • Patient classified in the high risk group of intracranial lesions according to SFMU criteria :
  • GCS score less than 15, 2 hours after the trauma
  • Focused neurological deficit
  • Post-traumatic convulsion
  • Suspicion of open fracture of the skull or embarrassment
  • Any sign of fracture of the base of the skull (hemotympanum, bilateral periorbital bruise, otorrhea or rhinorrhea of cerebrospinal fluid)
  • Treatment with anticoagulants
  • More than one episode of vomiting.
  • Patient classified in the group at low risk of intracranial lesions according to the SFMU criteria, presenting a GCS score of 15 without any criteria for moderate or high risk groups of intracranial lesions.
  • Patient consulting for moderate or severe head trauma (GCS score less than 13).
  • Refusal of the patient (signature of the opposition form).

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): NCT04543162


Contacts
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Contact: Lise Laclautre 04 73 75 11 95 promo_interne_drci@chu-clermontferrand.fr

Locations
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France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63000
Contact: Damien Bouvier       dbouvier@chu-clermontferrand.fr   
Principal Investigator: Damien Bouvier         
Sub-Investigator: Jeannot Schmidt         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Damien Bouvier University Hospital, Clermont-Ferrand
Publications:
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT04543162    
Other Study ID Numbers: RNI 2019 BOUVIER (Biotraumap)
2019-A01228-49 ( Other Identifier: ANSM )
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Glasgow Coma Scale (GCS) score of 15
S100B
Mild Traumatic Brain Injury
Brain biomarkers
Cerebral biomarkers
Intracranial lesions
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