Traumatic Brain Injury Clinical Trial
Official title:
Usefulness of Biomarkers in the Management of Mild Traumatic Brain Injury in Adults
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.
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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