Status:
UNKNOWN
Blood Biomarkers to Improve Management of Children With Traumatic Brain Injury
Lead Sponsor:
Nantes University Hospital
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
Up to 18 years
Phase:
NA
Brief Summary
Mild traumatic brain injury (TBI), defined by a Glasgow Coma Scale (GCS) score of 13 to 15, is the cause of many consultations in paediatric emergency departments (1), even though it is a rare cause o...
Eligibility Criteria
Inclusion
- Children and adolescents \<18 years old Consent from one of the parents of the child or from holder of parental responsibility Consent from the child or adolescent Parental affiliation with an appropriate health insurance system
- TBI population
- Admission within 24 hours of the injury
- Ability to follow-up by telephone, mail or email
- For the mTBI group:
- GCS score of 13-15 on admission
- Indication for cerebral CT scan according to national or local guidelines or the in-charge physician OR diagnosis of concussion consistent with the fourth Zurich consensus statement (9) . Concussion was defined as a complex pathophysiological process caused by a direct blow to the head, face, neck, or elsewhere on the body with an impulsive force transmitted to the head (which may or may not have involved loss of consciousness), resulting in a brain injury with one or more symptoms in one or more of the following clinical domains: somatic, cognitive, emotional or behavioural, or sleep. To objectively help diagnose concussion, the validated Acute Concussion Evaluation (ACE) questionnaire (10) for children with mTBI will be used, the presence of ≥ 1 symptom on the ACE defines concussion.
- For the moderate or severe TBI group:
- GCS score of 3-12 on admission
- Indication for cerebral CT scan according to national or local guidelines or the in-charge physician
- Non-TBI control paediatric population
- Admission for any reason other than TBI
- Indication of blood sampling for their routine management
- GCS score of 15
- Otherwise healthy, i.e. without chronic pathology
Exclusion
- TBI population
- Time of injury unknown or exceeding 24 hours
- Blood sampling not possible within 24 hours after the injury or 6 hours after the CT scan, if applicable
- Penetrating brain injury with skull fracture
- Pre-existing neurological disorders affecting the assessment of neurological outcome, seizure disorder/epilepsy, brain tumour, history of neurosurgery, stroke, encephalopathy
- Venepuncture not feasible
- Pregnant woman
- Intoxication
- No clear primary mechanism of trauma
- No possibility for transferring CT scan images to the centralised platform in case of neuroimaging only performed in an outside hospital before transfer
- Participation in another interventional research study
- Non-TBI control paediatric population
- Pre-existing neurological disorders, seizure disorder/epilepsy, brain tumour, history or indication of neurosurgery, stroke, encephalopathy
- History of TBI
- Orthopaedic trauma or surgery within the last month
- Suspected meningitidis or encephalitis
- Venepuncture not feasible
- Pregnant woman
- Intoxication
- Participation in another interventional research study
Key Trial Info
Start Date :
August 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
2880 Patients enrolled
Trial Details
Trial ID
NCT05413499
Start Date
August 2 2022
End Date
April 1 2025
Last Update
August 24 2022
Active Locations (20)
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1
Brest University Hospital
Brest, France
2
Clermont-Ferrand University Hospital
Clermont-Ferrand, France
3
Louis Mourier Hospital (AP-HP)
Colombes, France
4
Grenoble University Hospital
Grenoble, France