Phase
Condition
Traumatic Brain Injury
Memory Loss
Neurologic Disorders
Treatment
N/AClinical Study ID
Ages < 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Children and adolescents <18 years old Consent from one of the parents of the child or fromholder of parental responsibility Consent from the child or adolescent Parental affiliationwith 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 orthe in-charge physician OR diagnosis of concussion consistent with thefourth Zurich consensus statement (9) . Concussion was defined as a complexpathophysiological 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 abrain injury with one or more symptoms in one or more of the followingclinical domains: somatic, cognitive, emotional or behavioural, or sleep. Toobjectively help diagnose concussion, the validated Acute ConcussionEvaluation (ACE) questionnaire (10) for children with mTBI will be used, thepresence 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 orthe 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
Exclusion Criteria:
- TBI population
- Time of injury unknown or exceeding 24 hours
- Blood sampling not possible within 24 hours after the injury or 6 hours after theCT scan, if applicable
- Penetrating brain injury with skull fracture
- Pre-existing neurological disorders affecting the assessment of neurologicaloutcome, 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 incase 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
Study Design
Connect with a study center
Brest University Hospital
Brest,
FranceSite Not Available
Clermont-Ferrand University Hospital
Clermont-Ferrand,
FranceSite Not Available
Louis Mourier Hospital (AP-HP)
Colombes,
FranceSite Not Available
Grenoble University Hospital
Grenoble,
FranceSite Not Available
La Roche/Yon Hospital
La Roche-sur-Yon,
FranceSite Not Available
Lille University Hospital
Lille,
FranceSite Not Available
Limoges University Hospital
Limoges,
FranceSite Not Available
Lorient Hospital
Lorient,
FranceSite Not Available
Montpellier University Hospital
Montpellier,
FranceSite Not Available
Nantes University Hospital
Nantes,
FranceActive - Recruiting
Armand Trousseau hospital (AP-HP)
Paris,
FranceSite Not Available
Robert Debré Hospital (AP-HP)
Paris,
FranceSite Not Available
Rennes University Hospital
Rennes,
FranceSite Not Available
Saint Nazaire Hospital
Saint-Nazaire,
FranceSite Not Available
Saint Etienne University Hospital
Saint-Étienne,
FranceSite Not Available
Klinikum rechts der Isar, Technical University of Munich
Munich,
GermanySite Not Available
Hospital Universitari Vall d'Hebron (ICS)
Barcelona,
SpainSite Not Available
Hospital 12 de Octubre
Madrid,
SpainSite Not Available
Hospital Infantil Universitario Nino Jesus
Madrid,
SpainSite Not Available
Luzerner Kantonsspital
Lucerne,
SwitzerlandSite Not Available
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