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

NCT02855034 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2025-10-03

No results posted yet for this study

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

Interventions

OTHER

Blood samples

Blood samples for dosage: copeptin and protein S100B

Sponsors & Collaborators

  • Centre National de la Recherche Scientifique, France

    collaborator OTHER

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Gaëlle TOURNIAIRE, MD · Montpellier University Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-27
Primary Completion
2023-10-10
Completion
2023-10-10

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02855034 on ClinicalTrials.gov