Evaluation of Discriminating Power of Two Biomarkers in the Evaluation of Cerebral Lesions Due to Head Injuries in Infants and Children
- Conditions
- Traumatic Brain Injury
- Interventions
- Other: Blood samples
- Registration Number
- NCT02855034
- Lead Sponsor
- University Hospital, Montpellier
- 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 UCHL-1 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 UCHL1 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.
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 265
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Blood sample Blood samples All the patients performed the same blood samples for dosage: copeptin, S-100B, GFAP, NFL and UCHL-1 proteins
- Primary Outcome Measures
Name Time Method Copeptin dosage At the inclusion Dosage of copeptin to determine the copeptin's performance in diagnostic of traumatic brain injury
- Secondary Outcome Measures
Name Time Method S100B protein dosage At the inclusion Dosage of protein S100B to determine this protein's performance in diagnostic of traumatic brain injury
Tau dosage At the inclusion Dosage of Tau protein to determine this protein's performance in diagnostic of traumatic brain injury
UCHL-1 dosage At the inclusion Dosage of UCHL-1 protein to determine this protein's performance in diagnostic of traumatic brain injury
Combinaison of Copeptine, PS-100B, GFAP, Tau and UCHL-1 protein dosage At the inclusion Combination of these biomarkers to improve early discrimination of patients with brain injury secondary to CT.
GFAP protein dosage At the inclusion Dosage of GFAP protein to determine this protein's performance in diagnostic of traumatic brain injury
NFL protein dosage At the inclusion Dosage of NFL protein to determine this protein's performance in diagnostic of traumatic brain injury
Trial Locations
- Locations (1)
Montpellier University Hospital
🇫🇷Montpellier, France