Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A01228-49 | Other Identifier | ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with Mild Traumatic Brain Injury | patients with Mild Traumatic Brain Injury |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic value of cerebral biomarkers GFAP | Evaluate the diagnostic value of cerebral biomarkers GFAP (ng/L) | Day 0 |
| Diagnostic value of cerebral biomarkers UCH-L1 | Evaluate the diagnostic value of cerebral biomarkers UCH-L1 (ng/L) | Day 0 |
| Diagnostic value of cerebral biomarkers NSE | Evaluate the diagnostic value of cerebral biomarkers NSE (µg/L) | Day 0 |
| Diagnostic value of cerebral biomarkers Tau | Evaluate the diagnostic value of cerebral biomarkers TAU (ng/L) | Day 0 |
| Diagnostic value of cerebral biomarkers SBDP | Evaluate the diagnostic value of cerebral biomarkers SBDP (µg/L) | Day 0 |
| Diagnostic value of cerebral biomarkers NFL | Evaluate the diagnostic value of cerebral biomarkers NFL (ng/L) | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Utility of serum biomarker measurement with respect to reduction of the cost of management | Calculate this cost reduction compared to the cost of a cerebral tomodensitometry | Day 0 |
| Risk factors (antiplatelet agent) on biomarker results |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with mild Traumatic Brain Injury
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Damien Bouvier | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | 63000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29924734 | Background | Allouchery G, Moustafa F, Roubin J, Pereira B, Schmidt J, Raconnat J, Pic D, Sapin V, Bouvier D. Clinical validation of S100B in the management of a mild traumatic brain injury: issues from an interventional cohort of 1449 adult patients. Clin Chem Lab Med. 2018 Oct 25;56(11):1897-1904. doi: 10.1515/cclm-2018-0471. | |
| 16680008 | Background |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Collection of additional blood volume (approximately 7 mL) during blood tests provided as part of the usual medical care in emergencies
Collect information from medical records and assess the impact on biomarker results from statistical tests
| Day 0 |
| risk factors (loss of consciousness) on biomarker results | Collect information from medical records and assess the impact on biomarker results from statistical tests | Day 0 |
| risk factors (amnesia) on biomarker results | Collect information from medical records and assess the impact on biomarker results from statistical tests | Day 0 |
| Biberthaler P, Linsenmeier U, Pfeifer KJ, Kroetz M, Mussack T, Kanz KG, Hoecherl EF, Jonas F, Marzi I, Leucht P, Jochum M, Mutschler W. Serum S-100B concentration provides additional information fot the indication of computed tomography in patients after minor head injury: a prospective multicenter study. Shock. 2006 May;25(5):446-53. doi: 10.1097/01.shk.0000209534.61058.35. |
| 19654082 | Background | Bouvier D, Oddoze C, Ben Haim D, Moustafa F, Legrand A, Alazia M, Jehle E, Schmidt J, Sapin V. [Interest of S100B protein blood level determination for the management of patients with minor head trauma]. Ann Biol Clin (Paris). 2009 Jul-Aug;67(4):425-31. doi: 10.1684/abc.2009.0347. French. |
| 23102492 | Background | Calcagnile O, Unden L, Unden J. Clinical validation of S100B use in management of mild head injury. BMC Emerg Med. 2012 Oct 27;12:13. doi: 10.1186/1471-227X-12-13. |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D016489 | Head Injuries, Closed |
| D014949 | Wounds, Nonpenetrating |