Mild Traumatic Brain Injuryt-BIOMAPNCT06233851
BLOOD BIOMARKERS in PAEDIATRIC MTBI
An observational study of Mild Traumatic Brain Injury, run by Pediatric Clinical Research Platform at 1 site in Switzerland.
Trial summary
The goal of this observational study is to identify blood biomarkers that could help in the management of paediatric patients with mild TBI. The main questions it aims to answer are: 1. How can blood biomarkers reduce unnecessary CT scan and reduce the length of stay at the emergency department? 2. Read more about this study
- Who is it for?
- Ages 0 months to 16 years
- Conditions the study is for
- Mild Traumatic Brain Injury
- How many people
- 600 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Oct 2020to 8 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 months to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: paediatric patient suffering from a mild TBI within 24 hours
Who may be able to join
- mTBI within 24 hours
Who cannot join
- refusal of child or parents
- evidence of intoxication with alcohol or other substances
- history of TBI ( less than one month)
- epilepsy, encephalitis, meningitis, melanoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Paediatric Cohort Study of Biomarkers in the Early Management of Mild Traumatic Brain Injury and Prediction of Persistent Post-concussion Symptoms
The goal of this observational study is to identify blood biomarkers that could help in the management of paediatric patients with mild TBI. The main questions it aims to answer are:
- How can blood biomarkers reduce unnecessary CT scan and reduce the length of stay at the emergency department?
- How can blood biomarker predict post-concussion symptoms?
Participants will have a blood sample taken when they are admitted at emergency department and will receive a questionnaire describing their symptoms 14 days and 3 months after their trauma.
Read the detailed description
Mild Traumatic Brain Injury (mTBI) in children is a very frequent reason for presentation at the paediatric emergency department. In most cases, the trauma will not lead to intracranial lesions. The first objective for clinicians is therefore to detect all children in need of neurosurgical intervention after mTBI. Although computerized tomography (CT) is currently the modality of choice for acute intracranial haemorrhage identification, care should be taken to avoid unnecessary exposure to ionizing radiation in the developing brain. Monitoring the occurrence of bleeding usually involves an observation period which generally extends from six to twenty-four hours. This time is stressful for the child and parents as well as time and cost consuming for the hospital. In addition to the acute conditions, it has been described that post-concussion symptoms can occur in the weeks or months following the trauma, and neuropsychological follow-up of these children could help prevent or reduce the symptoms. The aim of our study is to find biomarkers that can identify children with clinically important intracranial injury and/or children that will eventually suffer from a post-concussion syndrome.
- Conditions
- Mild Traumatic Brain Injury
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| mTBI patient | Children <16 years-old who suffered a head trauma in the last 24 hours with signs of mild traumatic brain injury | |
| control | Children <16 years-old who have a scheduled blood test for any reason |
What is being measured
The primary outcome is the main question the study is designed to answer.
intracranial injuries on CT scan
Hemorrhage, oedema, traumatic infarction, diffuse axonal injury, pneumocephalus
Measured: Admission; within 24 hours
Post concussion symptoms
Such as persistent headache, fatigue, concentration difficulty etc. Evaluated by a neuropsychologist and results of the PCSI score (post concussion symptoms inventory)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start6 Oct 2020
- Primary completion10 Jun 2024
- Study completion8 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatric Clinical Research Platform
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio MANZANO, Pediatric Clinical Research Platform
- Investigators
- Sergio Manzano, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233851
- Sponsor's protocol ID
- 2020-01533
- Acronym
- t-BIOMAP
- Status last verified
- Nov 2024
- First submitted
- 16 Jan 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Paediatric Cohort Study of Biomarkers in the Early Management of Mild Traumatic Brain Injury and Prediction of Persistent Post-concussion Symptoms
- ClinicalTrials.gov ID
- NCT06233851
- Acronym / sponsor ID
- t-BIOMAP / 2020-01533
- Conditions
- Mild Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Pediatric Clinical Research PlatformUniversity, hospital or other
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 8 Jul 2024 (actual)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to identify blood biomarkers that could help in the management of paediatric patients with mild TBI. The main questions it aims to answer are:
- How can blood biomarkers reduce unnecessary CT scan and reduce the length of stay at the emergency department?
- How can blood biomarker predict post-concussion symptoms?
Participants will have a blood sample taken when they are admitted at emergency department and will receive a questionnaire describing their symptoms 14 days and 3 months after their trauma.
Detailed description
Mild Traumatic Brain Injury (mTBI) in children is a very frequent reason for presentation at the paediatric emergency department. In most cases, the trauma will not lead to intracranial lesions. The first objective for clinicians is therefore to detect all children in need of neurosurgical intervention after mTBI. Although computerized tomography (CT) is currently the modality of choice for acute intracranial haemorrhage identification, care should be taken to avoid unnecessary exposure to ionizing radiation in the developing brain. Monitoring the occurrence of bleeding usually involves an observation period which generally extends from six to twenty-four hours. This time is stressful for the child and parents as well as time and cost consuming for the hospital. In addition to the acute conditions, it has been described that post-concussion symptoms can occur in the weeks or months following the trauma, and neuropsychological follow-up of these children could help prevent or reduce the symptoms. The aim of our study is to find biomarkers that can identify children with clinically important intracranial injury and/or children that will eventually suffer from a post-concussion syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mTBI patient | – | –Children <16 years-old who suffered a head trauma in the last 24 hours with signs of mild traumatic brain injury |
| control | – | –Children <16 years-old who have a scheduled blood test for any reason |
Who may qualify
- Ages
- 0 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- paediatric patient suffering from a mild TBI within 24 hours
Key inclusion criteria (1 listed)
- mTBI within 24 hours
Key exclusion criteria (4 listed)
- refusal of child or parents
- evidence of intoxication with alcohol or other substances
- history of TBI ( less than one month)
- epilepsy, encephalitis, meningitis, melanoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
intracranial injuries on CT scan
Time frame: Admission; within 24 hours
Hemorrhage, oedema, traumatic infarction, diffuse axonal injury, pneumocephalus
Post concussion symptoms
Time frame: 3 months
Such as persistent headache, fatigue, concentration difficulty etc. Evaluated by a neuropsychologist and results of the PCSI score (post concussion symptoms inventory)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Mild Traumatic Brain Injury
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Virtual Reality in Rehabilitation of Executive Functions in Children With Mild or Moderate Traumatic Brain Injury
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Pilot TMS in Mild TBI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergio Manzano, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Traumatic Brain Injury, run by Pediatric Clinical Research Platform at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intracranial injuries on CT scan (time frame: Admission; within 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.