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

Traumatic Brain Injury Clinical Trial

— Biotraumap  

Official title:

Usefulness of Biomarkers in the Management of Mild Traumatic Brain Injury in Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04543162
• Other study ID #: RNI 2019 BOUVIER (Biotraumap)
• Secondary ID: 2019-A01228-49
• Status: Recruiting
• Start date: October 2, 2019
• Est. completion date: February 2023

Study information

• Verified date: August 2020
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 04 73 75 11 95
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: February 2023
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Intracranial Injury
• Traumatic Brain Injury
• Wounds and Injuries

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Calcagnile O, Undén L, Undén 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic value of cerebral biomarkers GFAP	Evaluate the diagnostic value of cerebral biomarkers GFAP (ng/L)	Day 0
Primary	Diagnostic value of cerebral biomarkers UCH-L1	Evaluate the diagnostic value of cerebral biomarkers UCH-L1 (ng/L)	Day 0
Primary	Diagnostic value of cerebral biomarkers NSE	Evaluate the diagnostic value of cerebral biomarkers NSE (µg/L)	Day 0
Primary	Diagnostic value of cerebral biomarkers Tau	Evaluate the diagnostic value of cerebral biomarkers TAU (ng/L)	Day 0
Primary	Diagnostic value of cerebral biomarkers SBDP	Evaluate the diagnostic value of cerebral biomarkers SBDP (µg/L)	Day 0
Primary	Diagnostic value of cerebral biomarkers NFL	Evaluate the diagnostic value of cerebral biomarkers NFL (ng/L)	Day 0
Secondary	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
Secondary	Risk factors (antiplatelet agent) on biomarker results	Collect information from medical records and assess the impact on biomarker results from statistical tests	Day 0
Secondary	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
Secondary	risk factors (amnesia) on biomarker results	Collect information from medical records and assess the impact on biomarker results from statistical tests	Day 0