Usefulness of Biomarkers in the Management of Mild Traumatic Brain Injury in Adults (Biotraumap)
- Conditions
- Traumatic Brain InjuryIntracranial Injury
- Registration Number
- NCT04543162
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1025
- 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.
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic value of cerebral biomarkers GFAP Day 0 Evaluate the diagnostic value of cerebral biomarkers GFAP (ng/L)
Diagnostic value of cerebral biomarkers NSE Day 0 Evaluate the diagnostic value of cerebral biomarkers NSE (µg/L)
Diagnostic value of cerebral biomarkers UCH-L1 Day 0 Evaluate the diagnostic value of cerebral biomarkers UCH-L1 (ng/L)
Diagnostic value of cerebral biomarkers Tau Day 0 Evaluate the diagnostic value of cerebral biomarkers TAU (ng/L)
Diagnostic value of cerebral biomarkers SBDP Day 0 Evaluate the diagnostic value of cerebral biomarkers SBDP (µg/L)
Diagnostic value of cerebral biomarkers NFL Day 0 Evaluate the diagnostic value of cerebral biomarkers NFL (ng/L)
- Secondary Outcome Measures
Name Time Method Utility of serum biomarker measurement with respect to reduction of the cost of management Day 0 Calculate this cost reduction compared to the cost of a cerebral tomodensitometry
risk factors (amnesia) on biomarker results Day 0 Collect information from medical records and assess the impact on biomarker results from statistical tests
risk factors (loss of consciousness) on biomarker results Day 0 Collect information from medical records and assess the impact on biomarker results from statistical tests
Risk factors (antiplatelet agent) on biomarker results Day 0 Collect information from medical records and assess the impact on biomarker results from statistical tests
Trial Locations
- Locations (1)
CHU Clermont-Ferrand
🇫🇷Clermont-Ferrand, France