CHU Clermont-Ferrand
Clermont-Ferrand, 63000, France
NCT Number: NCT04543162
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.
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Notify Me18 year and older
All sexes
Observational
Clermont-Ferrand, 63000, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Day 0
Evaluate the diagnostic value of cerebral biomarkers GFAP (ng/L)
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Evaluate the diagnostic value of cerebral biomarkers UCH-L1 (ng/L)
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Evaluate the diagnostic value of cerebral biomarkers NSE (µg/L)
Time frame: Day 0
Evaluate the diagnostic value of cerebral biomarkers TAU (ng/L)
Time frame: Day 0
Evaluate the diagnostic value of cerebral biomarkers SBDP (µg/L)
Time frame: Day 0
Evaluate the diagnostic value of cerebral biomarkers NFL (ng/L)
Time frame: Day 0
Calculate this cost reduction compared to the cost of a cerebral tomodensitometry
Time frame: Day 0
Collect information from medical records and assess the impact on biomarker results from statistical tests
Time frame: Day 0
Collect information from medical records and assess the impact on biomarker results from statistical tests
Time frame: Day 0
Collect information from medical records and assess the impact on biomarker results from statistical tests
University Hospital, Clermont-Ferrand
Other
Usefulness of Biomarkers in the Management of Mild Traumatic Brain Injury in Adults
Acronym: Biotraumap
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