Evaluation of Discriminating Power of Two Biomarkers in the Evaluation of Cerebral Lesions Due to Head Injuries in Infants and Children
NCT ID: NCT02855034
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
167 participants
INTERVENTIONAL
2016-05-27
2023-10-10
Brief Summary
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It is the first clinical biological evaluation of severity of head injury based on dosing of copeptin alone or associated with protein S100B.
Furthermore, the evaluation of the biomarkers GFAP, NFL, Tau and UCH-L1 is today necessary from a scientific point of view and to optimize the diagnostic and prognostic value of these biomarkers which can be combined. Indeed, these protein biomarkers are biologically linked to the protein S100B and copeptin, and will allow a more specific and more thorough evaluation of the presence of brain damage at the cellular level. More specifically, the measurement of the S-100B and GFAP proteins will allow evaluation of gliovascular damage while those of copeptin, NFL, Tau and UCH-L1 proteins will allow evaluation of neuronal damage. The assay of these different biomarkers will also be carried out on a control population, without head injury or neurological or inflammatory pathologies, in order to establish the standards of these biomarkers on a pediatric population of similar age.
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Detailed Description
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Each patient will attend a visit of inclusion and a blood sample. Just patients with a suspicion of head injury have a visit at 96 hours +/- 24 hours after the inclusion: this visit is made by phone. The patient and his parents will have to answer to a phone questionnaire
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Blood sample
All the patients performed the same blood samples for dosage: copeptin, S-100B, GFAP, NFL and UCHL-1 proteins
Blood samples
Blood samples for dosage: copeptin and protein S100B
Interventions
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Blood samples
Blood samples for dosage: copeptin and protein S100B
Eligibility Criteria
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Inclusion Criteria
* Cranial trauma with indication of brain scanner according to risk of clinically important traumatic brain injury (high or intermediate risk), according the clinical prediction rule Pediatric Emergency Care Applied Research Network (PECARN)
* Period of 6 hours of less after cranial trauma
* Informed and written consent from one of the parents or legal representatives
* Patient must be covered by a french social security scheme
* Paediatric patients aged 3 months up to 15 years admitted to the emergency room for whom a blood sample is required
* Informed and written consent from one of the parents or legal representatives
* Patient must be covered by a french social security scheme
Exclusion Criteria
* Coagulation disorder
* Multiple accidental trauma
* Evocative elements of mistreatment
* Cranial trauma ou suspicion of cranial trauma
* brain pathology including migraines
* Febrile syndrome
* Chronic inflammatory pathology
* Known bleeding disorder
* Evocative elements of mistreatment
3 Months
15 Years
ALL
No
Sponsors
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Centre National de la Recherche Scientifique, France
OTHER
University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Gaëlle TOURNIAIRE, MD
Role: PRINCIPAL_INVESTIGATOR
Montpellier University Hospital
Locations
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Montpellier University Hospital
Montpellier, , France
Countries
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References
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Babcock L, Byczkowski T, Mookerjee S, Bazarian JJ. Ability of S100B to predict severity and cranial CT results in children with TBI. Brain Inj. 2012;26(11):1372-80. doi: 10.3109/02699052.2012.694565. Epub 2012 Jun 22.
Beaudeux JL, Laribi S. [S100B protein serum level as a biomarker of minor head injury]. Ann Biol Clin (Paris). 2013 Nov;71:71-8. doi: 10.1684/abc.2013.0901. French.
Bechtel K, Frasure S, Marshall C, Dziura J, Simpson C. Relationship of serum S100B levels and intracranial injury in children with closed head trauma. Pediatrics. 2009 Oct;124(4):e697-704. doi: 10.1542/peds.2008-1493. Epub 2009 Sep 28.
Bouvier D. [Interest of S100B protein blood level determination in severe or moderate head injury]. Ann Biol Clin (Paris). 2013 Mar-Apr;71(2):145-50. doi: 10.1684/abc.2013.0812. French.
Bouvier D, Fournier M, Dauphin JB, Amat F, Ughetto S, Labbe A, Sapin V. Serum S100B determination in the management of pediatric mild traumatic brain injury. Clin Chem. 2012 Jul;58(7):1116-22. doi: 10.1373/clinchem.2011.180828. Epub 2012 Apr 23.
Janigro D, Bailey DM, Lehmann S, Badaut J, O'Flynn R, Hirtz C, Marchi N. Peripheral Blood and Salivary Biomarkers of Blood-Brain Barrier Permeability and Neuronal Damage: Clinical and Applied Concepts. Front Neurol. 2021 Feb 4;11:577312. doi: 10.3389/fneur.2020.577312. eCollection 2020.
Lin C, Wang N, Shen ZP, Zhao ZY. Plasma copeptin concentration and outcome after pediatric traumatic brain injury. Peptides. 2013 Apr;42:43-7. doi: 10.1016/j.peptides.2013.01.015. Epub 2013 Feb 8.
Mathews JD, Forsythe AV, Brady Z, Butler MW, Goergen SK, Byrnes GB, Giles GG, Wallace AB, Anderson PR, Guiver TA, McGale P, Cain TM, Dowty JG, Bickerstaffe AC, Darby SC. Cancer risk in 680,000 people exposed to computed tomography scans in childhood or adolescence: data linkage study of 11 million Australians. BMJ. 2013 May 21;346:f2360. doi: 10.1136/bmj.f2360.
Mihindu E, Bhullar I, Tepas J, Kerwin A. Computed tomography of the head in children with mild traumatic brain injury. Am Surg. 2014 Sep;80(9):841-3.
Pearce MS, Salotti JA, Little MP, McHugh K, Lee C, Kim KP, Howe NL, Ronckers CM, Rajaraman P, Sir Craft AW, Parker L, Berrington de Gonzalez A. Radiation exposure from CT scans in childhood and subsequent risk of leukaemia and brain tumours: a retrospective cohort study. Lancet. 2012 Aug 4;380(9840):499-505. doi: 10.1016/S0140-6736(12)60815-0. Epub 2012 Jun 7.
Segui-Gomez M, MacKenzie EJ. Measuring the public health impact of injuries. Epidemiol Rev. 2003;25:3-19. doi: 10.1093/epirev/mxg007. No abstract available.
Yang DB, Yu WH, Dong XQ, Du Q, Shen YF, Zhang ZY, Zhu Q, Che ZH, Liu QJ, Wang H, Jiang L, Du YF. Plasma copeptin level predicts acute traumatic coagulopathy and progressive hemorrhagic injury after traumatic brain injury. Peptides. 2014 Aug;58:26-9. doi: 10.1016/j.peptides.2014.05.015. Epub 2014 Jun 4.
Yu GF, Huang Q, Dai WM, Jie YQ, Fan XF, Wu A, Lv Y, Li YP, Yan XJ. Prognostic value of copeptin: one-year outcome in patients with traumatic brain injury. Peptides. 2012 Jan;33(1):164-9. doi: 10.1016/j.peptides.2011.11.017. Epub 2011 Nov 26.
Zhang ZY, Zhang LX, Dong XQ, Yu WH, Du Q, Yang DB, Shen YF, Wang H, Zhu Q, Che ZH, Liu QJ, Jiang L, Du YF. Comparison of the performances of copeptin and multiple biomarkers in long-term prognosis of severe traumatic brain injury. Peptides. 2014 Oct;60:13-7. doi: 10.1016/j.peptides.2014.07.016. Epub 2014 Jul 27.
Related Links
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US Department of Health and Human Services. Center for Disease Control and Prevention. Traumatic brain injury in the United States : Emergency department visits, hospitalizations and deaths 2002-2006.
Other Identifiers
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2015-A00553-46
Identifier Type: OTHER
Identifier Source: secondary_id
9546
Identifier Type: -
Identifier Source: org_study_id
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