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Traumatic Brain InjuryTCOP100NCT02855034

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

A study testing Blood samples in people with Traumatic Brain Injury, run by University Hospital, Montpellier at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 months to 15 years
Conditions the study is for
Traumatic Brain Injury
What is being tested?
Blood samples
Could I receive a placebo?
No, everyone receives an active treatment
How many people
167 participants
Where
1 siteFrance
Study dates
27 May 2016to 10 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 months to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Febrile syndrome
  • Chronic inflammatory pathology
  • Known bleeding disorder
  • Evocative elements of mistreatment

Trial locations and contacts

1 site in 1 country.

France1 site

  • Montpellier University Hospital

    Montpellier, 34295

Other trials in France

About this study

Official title: Evaluation of Discriminating Power of Two Biomarkers (Protein S100B/Copeptin) in the Evaluation of Cerebral Lesions Due to Head Injuries in Infants and Children

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.

Read the detailed description

265 children or infants will be recruited during 84 months. 220 patients with a suspicion of head injury and 45 patients without head injury.

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

Being tested
Blood samples
Keywords
child and infant, Blood samples
Medical subject headings
Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood samplesOther

    Blood samples for dosage: copeptin and protein S100B

Study groups in NCT02855034
Study groupRoleWhat they receive
Blood sampleOtherAll the patients performed the same blood samples for dosage: copeptin, S-100B, GFAP, NFL and UCHL-1 proteins
Receives: Other: Blood samples

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Copeptin dosage

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

    Measured: At the inclusion

Secondary outcomes (6)

  1. S100B protein dosage

    Dosage of protein S100B to determine this protein's performance in diagnostic of traumatic brain injury

    Measured: At the inclusion

  2. GFAP protein dosage

    Dosage of GFAP protein to determine this protein's performance in diagnostic of traumatic brain injury

    Measured: At the inclusion

  3. NFL protein dosage

    Dosage of NFL protein to determine this protein's performance in diagnostic of traumatic brain injury

    Measured: At the inclusion

  4. Tau dosage

    Dosage of Tau protein to determine this protein's performance in diagnostic of traumatic brain injury

    Measured: At the inclusion

  5. UCH-L1 dosage

    Dosage of UCH-L1 protein to determine this protein's performance in diagnostic of traumatic brain injury

    Measured: At the inclusion

  6. Combinaison of Copeptine, PS-100B, GFAP, Tau and UCH-L1 protein dosage

    Combination of these biomarkers to improve early discrimination of patients with brain injury secondary to CT.

    Measured: At the inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2016 (estimated)
  2. Study start27 May 2016
  3. Primary completion10 Oct 2023
  4. Study completion10 Oct 2023

Why it stopped: Difficulties in recruiting control patients to the emergency department

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
167 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02855034
Sponsor's protocol ID
9546
Other IDs
2015-A00553-46
Acronym
TCOP100
Status last verified
Sep 2025
First submitted
1 Aug 2016
Last updated
3 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22725661

  • 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.

    PubMed 24235330

  • 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.

    PubMed 19786430

  • 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.

    PubMed 23587577

  • 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.

    PubMed 22529109

  • 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.

    PubMed 33613412

  • 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.

    PubMed 23402790

  • 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.

    PubMed 23694687

  • 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.

    PubMed 25197865

  • 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.

    PubMed 22681860

  • 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.

    PubMed 12923986

  • 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.

    PubMed 24905622

  • 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.

    PubMed 22138140

  • 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.

    PubMed 25076464

Questions about this trial

What is this clinical trial studying?

A study testing Blood samples in people with Traumatic Brain Injury, run by University Hospital, Montpellier at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Difficulties in recruiting control patients to the emergency department). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Copeptin dosage (time frame: At the inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02855034, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.

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