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Blood Biomarkers to Improve Management of Children With Traumatic Brain Injury (BRAINI2)

Primary Purpose

Traumatic Brain Injury

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Biomarkers research
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Traumatic Brain Injury focused on measuring TBI / Biomarkers / paediatric

Eligibility Criteria

0 Days - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

  1. 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

  2. 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 Criteria:

  1. 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

  2. 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

Sites / Locations

  • Brest University Hospital
  • Clermont-Ferrand University Hospital
  • Louis Mourier Hospital (AP-HP)
  • Grenoble University Hospital
  • La Roche/Yon Hospital
  • Lille University Hospital
  • Limoges University Hospital
  • Lorient Hospital
  • Montpellier University Hospital
  • Nantes University HospitalRecruiting
  • Armand Trousseau hospital (AP-HP)
  • Robert Debré Hospital (AP-HP)
  • Rennes University Hospital
  • Saint Nazaire Hospital
  • Saint Etienne University Hospital
  • Klinikum rechts der Isar, Technical University of Munich
  • Hospital Universitari Vall d'Hebron (ICS)
  • Hospital 12 de Octubre
  • Hospital Infantil Universitario Nino Jesus
  • Luzerner Kantonsspital

Outcomes

Primary Outcome Measures

Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of GFAP and UCHL-1 used separately and in combination to detect the presence or absence of ICL on CT scan

Secondary Outcome Measures

Prediction of early and mid-term prognosis after TBI : Number of participants with Early clinical worsening
Early clinical worsening defined by the occurrence of death from TBI, neurosurgical intervention, intubation for TBI, or hospital admission of two nights or more associated with ICL on CT scan for persistent neurological symptoms such as persistent alteration in mental status, recurrent emesis due to TBI, persistent severe headache, or ongoing seizure management (8), within 72 hours after TBI.
Prediction of early and mid-term prognosis after TBI : Glasgow Outcome Scale-Extended, paediatric version (GOS-E Peds)
Neurological outcome: Glasgow Outcome Scale-Extended, paediatric version (GOS-E Peds)
Prediction of early and mid-term prognosis after TBI : ost-concussion symptoms: Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
Post-concussion symptoms: Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
Prediction of early and mid-term prognosis after TBI : Health related quality of life: PedsQL questionnaire
Health related quality of life: PedsQL questionnaires
Prediction of early and mid-term prognosis after TBI : Serum GFAP and UCH-L1 concentrations
Comparison of serum GFAP and UCH-L1 concentrations according to the TBI severity groups, i.e. mild (GCS score of 13-15), moderate (GCS score of 9-12) or severe (GCS score of 3-8)
Establishment of age-appropriate physiological reference values
Measure of serum GFAP and UCH-L1 concentrations in three age groups (under 2 years old, 2-9 years old and aged 10 and over) in a non-TBI control paediatric population

Full Information

First Posted
June 1, 2022
Last Updated
August 19, 2022
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05413499
Brief Title
Blood Biomarkers to Improve Management of Children With Traumatic Brain Injury
Acronym
BRAINI2
Official Title
BRAINI2-Paediatric : Blood Biomarkers to Improve Management of Children With Traumatic Brain Injury: a European, Prospective, Multicentre Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2022 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 of acute complication: approximately 10% of children present with intracranial lesions (ICL) on the CT scan and less than 1% require neurosurgical intervention (2). Although ICLs remain a serious complication requiring rapid diagnosis, brain CT scans, the gold standard diagnostic test, cannot be performed routinely because many children would be unnecessarily exposed to ionising radiation associated with an increased risk of cancer (3). In recent years, several clinical decision rules for the management of mTBI have therefore been developed with the aim of identifying children at high or very low risk of ICL in order to better target CT scan indications. Despite this, the rate of CT scans performed has remained high, up to 35%, and has not decreased with the application of these clinical decision rules (4). Furthermore, even though the majority of children and adolescents recover quickly after mTBI, nearly 30% will present symptoms such as headaches, dizziness, asthenia, memory, concentration or sleep disorders persisting beyond one month with a possible impact on their quality of life (5). Thus, there is a need to develop new strategies to (i) limit the use of CT scans while minimising the risk of late diagnosis of ICL, (ii) identify children with a higher risk of adverse outcome and/or post-concussive symptoms. One of the most promising strategies is the use of brain-based blood biomarkers. This study therefore aims to provide new knowledge on two of them, GFAP and UCH-L1 (6,7), in particular by using an automated test combining them (the VIDAS® TBI test developed by bioMérieux) in order to improve the management of CT in the paediatric population at the diagnostic and prognostic levels.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
TBI / Biomarkers / paediatric

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2880 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Biomarkers research
Intervention Description
For a part of the included population, the children with a mTBI and without indication of CT scan, a non-routine blood sample will be planned
Primary Outcome Measure Information:
Title
Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of GFAP and UCHL-1 used separately and in combination to detect the presence or absence of ICL on CT scan
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Prediction of early and mid-term prognosis after TBI : Number of participants with Early clinical worsening
Description
Early clinical worsening defined by the occurrence of death from TBI, neurosurgical intervention, intubation for TBI, or hospital admission of two nights or more associated with ICL on CT scan for persistent neurological symptoms such as persistent alteration in mental status, recurrent emesis due to TBI, persistent severe headache, or ongoing seizure management (8), within 72 hours after TBI.
Time Frame
72 hours after TBI
Title
Prediction of early and mid-term prognosis after TBI : Glasgow Outcome Scale-Extended, paediatric version (GOS-E Peds)
Description
Neurological outcome: Glasgow Outcome Scale-Extended, paediatric version (GOS-E Peds)
Time Frame
Month 1, Month 3
Title
Prediction of early and mid-term prognosis after TBI : ost-concussion symptoms: Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
Description
Post-concussion symptoms: Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
Time Frame
Month 1, Month 3
Title
Prediction of early and mid-term prognosis after TBI : Health related quality of life: PedsQL questionnaire
Description
Health related quality of life: PedsQL questionnaires
Time Frame
Month 1, Month 3
Title
Prediction of early and mid-term prognosis after TBI : Serum GFAP and UCH-L1 concentrations
Description
Comparison of serum GFAP and UCH-L1 concentrations according to the TBI severity groups, i.e. mild (GCS score of 13-15), moderate (GCS score of 9-12) or severe (GCS score of 3-8)
Time Frame
Day 0
Title
Establishment of age-appropriate physiological reference values
Description
Measure of serum GFAP and UCH-L1 concentrations in three age groups (under 2 years old, 2-9 years old and aged 10 and over) in a non-TBI control paediatric population
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fleur LORTON
Phone
33 (0)2 40 08 33 33
Email
fleur.lorton@chu-nantes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fleur LORTON
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brest University Hospital
City
Brest
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lydie ABALEA
First Name & Middle Initial & Last Name & Degree
Lydie ABALEA
Facility Name
Clermont-Ferrand University Hospital
City
Clermont-Ferrand
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadia SAVY
First Name & Middle Initial & Last Name & Degree
Nadia SAVY
Facility Name
Louis Mourier Hospital (AP-HP)
City
Colombes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thibault DE GROC
First Name & Middle Initial & Last Name & Degree
Thibault DE GROC
Facility Name
Grenoble University Hospital
City
Grenoble
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliette MASSOT
First Name & Middle Initial & Last Name & Degree
Juliette MASSOT
Facility Name
La Roche/Yon Hospital
City
La Roche-sur-Yon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ophélia LE GENTIL
First Name & Middle Initial & Last Name & Degree
Ophélia LE GENTIL
Facility Name
Lille University Hospital
City
Lille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François DUBOS
First Name & Middle Initial & Last Name & Degree
François DUBOS
Facility Name
Limoges University Hospital
City
Limoges
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alban LASPOUGEAS
First Name & Middle Initial & Last Name & Degree
Alban LASPOUGEAS
Facility Name
Lorient Hospital
City
Lorient
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cédric MENAGER
First Name & Middle Initial & Last Name & Degree
Cédric MENAGER
Facility Name
Montpellier University Hospital
City
Montpellier
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaëlle TOURNIAIRE
First Name & Middle Initial & Last Name & Degree
Gaëlle TOURNIAIRE
Facility Name
Nantes University Hospital
City
Nantes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fleur LORTON
First Name & Middle Initial & Last Name & Degree
Fleur LORTON
Facility Name
Armand Trousseau hospital (AP-HP)
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sidney PASSAT
First Name & Middle Initial & Last Name & Degree
Sidney PASSAT
Facility Name
Robert Debré Hospital (AP-HP)
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hélène LIENARD
First Name & Middle Initial & Last Name & Degree
Hélène LIENARD
Facility Name
Rennes University Hospital
City
Rennes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Véronique CHASLE
First Name & Middle Initial & Last Name & Degree
Véronique CHASLE
Facility Name
Saint Nazaire Hospital
City
Saint-Nazaire
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Amélie CHENE
First Name & Middle Initial & Last Name & Degree
Marie-Amélie CHENE
Facility Name
Saint Etienne University Hospital
City
Saint-Étienne
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aymeric CANTAIS
First Name & Middle Initial & Last Name & Degree
Aymeric CANTAIS
Facility Name
Klinikum rechts der Isar, Technical University of Munich
City
Munich
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter BIBERTHALER
First Name & Middle Initial & Last Name & Degree
Peter BIBERTHALER
Facility Name
Hospital Universitari Vall d'Hebron (ICS)
City
Barcelona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria A POCA
First Name & Middle Initial & Last Name & Degree
Maria A POCA
Facility Name
Hospital 12 de Octubre
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfonso LAGARES
First Name & Middle Initial & Last Name & Degree
Alfonso LAGARES
Facility Name
Hospital Infantil Universitario Nino Jesus
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Belen RIVERO
First Name & Middle Initial & Last Name & Degree
Belen RIVERO
Facility Name
Luzerner Kantonsspital
City
Lucerne
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markus LEHNER
First Name & Middle Initial & Last Name & Degree
Markus LEHNER

12. IPD Sharing Statement

Plan to Share IPD
No

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Blood Biomarkers to Improve Management of Children With Traumatic Brain Injury

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