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

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 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.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Other: Blood samples

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 (Anticipated): 265
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gaëlle TOURNIAIRE, MD; Phone Number: +33 4 67 33 22 86; Email: g-tourniaire@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • Montpellier University Hospital
    • Contact: Gaëlle TOURNIAIRE, MD; Email: g-tourniaire@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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	Dosage of protein S100B to determine this protein's performance in diagnostic of traumatic brain injury	At the inclusion
GFAP protein dosage	Dosage of GFAP protein to determine this protein's performance in diagnostic of traumatic brain injury	At the inclusion
NFL protein dosage	Dosage of NFL protein to determine this protein's performance in diagnostic of traumatic brain injury	At the inclusion
Tau dosage	Dosage of Tau protein to determine this protein's performance in diagnostic of traumatic brain injury	At the inclusion
UCHL-1 dosage	Dosage of UCHL-1 protein to determine this protein's performance in diagnostic of traumatic brain injury	At the inclusion
Combinaison of Copeptine, PS-100B, GFAP, Tau and UCHL-1 protein dosage	Combination of these biomarkers to improve early discrimination of patients with brain injury secondary to CT.	At the inclusion

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2016
• Primary Completion (Anticipated): November 26, 2023
• Study Completion (Anticipated): December 26, 2023

Study Registration Dates

• First Submitted: August 1, 2016
• First Submitted That Met QC Criteria: August 1, 2016
• First Posted (Estimate): August 4, 2016

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 10, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Blood samples; child and infant
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Craniocerebral Trauma
• Other Study ID Numbers: UF 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