Evaluation of Discriminating Power of Two Biomarkers in the Evaluation of Cerebral Lesions Due to Head Injuries in Infants and Children (TCOP100)

September 29, 2025 updated by: University Hospital, Montpellier

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

167

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Montpellier University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 15 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion criteria for the Target Population:

  • 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

Inclusion criteria for the Control Population:

  • 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 for the Target Population:

  • A pre-existing intracranial injury or malformation, or osteogenesis imperfecta
  • Coagulation disorder
  • Multiple accidental trauma
  • Evocative elements of mistreatment

Exclusion criteria for the Control Population:

  • Cranial trauma ou suspicion of cranial trauma
  • brain pathology including migraines
  • Febrile syndrome
  • Chronic inflammatory pathology
  • Known bleeding disorder
  • Evocative elements of mistreatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Blood sample
All the patients performed the same blood samples for dosage: copeptin, S-100B, GFAP, NFL and UCHL-1 proteins
Other: Blood samples
Blood samples for dosage: copeptin and protein S100B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Copeptin dosage
Time Frame: At the inclusion
Dosage of copeptin to determine the copeptin's performance in diagnostic of traumatic brain injury
At the inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
S100B protein dosage
Time Frame: At the inclusion
Dosage of protein S100B to determine this protein's performance in diagnostic of traumatic brain injury
At the inclusion
GFAP protein dosage
Time Frame: At the inclusion
Dosage of GFAP protein to determine this protein's performance in diagnostic of traumatic brain injury
At the inclusion
NFL protein dosage
Time Frame: At the inclusion
Dosage of NFL protein to determine this protein's performance in diagnostic of traumatic brain injury
At the inclusion
Tau dosage
Time Frame: At the inclusion
Dosage of Tau protein to determine this protein's performance in diagnostic of traumatic brain injury
At the inclusion
UCH-L1 dosage
Time Frame: At the inclusion
Dosage of UCH-L1 protein to determine this protein's performance in diagnostic of traumatic brain injury
At the inclusion
Combinaison of Copeptine, PS-100B, GFAP, Tau and UCH-L1 protein dosage
Time Frame: At the inclusion
Combination of these biomarkers to improve early discrimination of patients with brain injury secondary to CT.
At the inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

Centre National de la Recherche Scientifique, France

Investigators

  • Principal Investigator: Gaëlle TOURNIAIRE, MD, Montpellier University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2016

Primary Completion (Actual)

October 10, 2023

Study Completion (Actual)

October 10, 2023

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

August 1, 2016

First Posted (Estimated)

August 4, 2016

Study Record Updates

Last Update Posted (Estimated)

October 3, 2025

Last Update Submitted That Met QC Criteria

September 29, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9546
  • 2015-A00553-46 (Other Identifier: Agence Nationale de Sécurité des Médicaments)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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