NCT04543162|Completed
Usefulness of Biomarkers in the Management of Mild Traumatic Brain Injury in Adults (Biotraumap)
Biotraumap
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Biotraumap
Sponsor study identifier
Secondary identifiers
OTHER · ANSM
observational
1,025
1 country
1
Study Start
October 2, 2019
Actual (reported)Primary Completion
August 28, 2024
Actual (reported)Study Completion
August 28, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 28, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 26, 2019
Actual (reported)October 2, 2019
Actual (reported)September 10, 2020
Actual (reported)August 28, 2024
Actual (reported)August 28, 2024
Actual (reported)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
Utility of serum biomarker measurement with respect to reduction of the cost of management
Day 0
Risk factors (antiplatelet agent) on biomarker results
Day 0
risk factors (loss of consciousness) on biomarker results
Day 0
risk factors (amnesia) on biomarker results
Day 0
patients with Mild Traumatic Brain Injury
Patients with mild Traumatic Brain Injury
CHU Clermont-Ferrand
Clermont-Ferrand, 63000, France
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.
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.
Collection of additional blood volume (approximately 7 mL) during blood tests provided as part of the usual medical care in emergencies
Damien Bouvier
University Hospital, Clermont-Ferrand
1,025 participants (actual enrollment reported by the registry).
First Submitted
September 26, 2019
First Posted
September 10, 2020
Study Start
October 2, 2019
Actual (reported)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
Contact the study team to confirm eligibility.
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.
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.
Primary Completion
August 28, 2024
Actual (reported)Study Completion
August 28, 2024
Actual (reported)Last Updated
October 8, 2024
Record last verified: 2024-10
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Source: ClinicalTrials.gov.
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