Evaluation of Discriminating Power of Two Biomarkers in the Evaluation of Cerebral Lesions Due to Head Injuries in Infants and Children

NCT02855034 | Terminated

• 2 other identifiers: 95462015-A00553-46
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

Brief Summary

Head injury is a frequent motive of consultation in paediatric emergency units and the first cause of mortality in infants of more than one year old in developped countries. The indication of performing cerebral CT scans currently depends on clinical decision based on recommendations used in adults. In this way, 60 to 90% of scans are normal in children with head injury. CT scan is expensive and irradiating with the risk of increasing the cancer in children. Protein S100B and copeptin are biomarkers which have shown their ability to detect cerebral lesion in children with head injury. (protein S100B and /or in adults protein S100B and copetin). 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.

Conditions

Traumatic Brain Injury

Keywords

child and infant; Blood samples

Outcome Measures

Primary Outcomes (1)

• Copeptin dosage

  Dosage of copeptin to determine the copeptin's performance in diagnostic of traumatic brain injury

  At the inclusion

Secondary Outcomes (6)

• S100B protein dosage

  At the inclusion

• GFAP protein dosage

  At the inclusion

• NFL protein dosage

  At the inclusion

• Tau dosage

  At the inclusion

• UCH-L1 dosage

  At the inclusion

Study Arms (1)

Blood sample

OTHER

All the patients performed the same blood samples for dosage: copeptin, S-100B, GFAP, NFL and UCHL-1 proteins

Other: Blood samples

Interventions

Blood samples OTHER

Blood samples for dosage: copeptin and protein S100B

Blood sample

Eligibility Criteria

• Age: 3 Months - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Paediatric patients aged 3 months up to 15 years
• 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

You may not qualify if:

• A pre-existing intracranial injury or malformation, or osteogenesis imperfecta
• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Centre National de la Recherche Scientifique, France: collaborator

Study Sites (1)

Montpellier University Hospital

Montpellier, 34295, France

Location

Related Publications (14)

• 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.

  PMID: 22725661 BACKGROUND

• 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.

  PMID: 24235330 BACKGROUND

• 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.

  PMID: 19786430 BACKGROUND

• 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.

  PMID: 23587577 BACKGROUND

• 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.

  PMID: 22529109 BACKGROUND

• 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.

  PMID: 33613412 BACKGROUND

• 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.

  PMID: 23402790 BACKGROUND

• 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.

  PMID: 23694687 BACKGROUND

• 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.

  PMID: 25197865 BACKGROUND

• 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.

  PMID: 22681860 BACKGROUND

• 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.

  PMID: 12923986 BACKGROUND

• 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.

  PMID: 24905622 BACKGROUND

• 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.

  PMID: 22138140 BACKGROUND

• 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.

  PMID: 25076464 BACKGROUND

Related Links

• 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.

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Gaëlle TOURNIAIRE, MD

  Montpellier University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 4, 2016
• Study Start: May 27, 2016
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2023
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)