Brain Injuries, TraumaticNCT04288167
Biochemical Diagnostics of Mild Traumatic Brain Injury (TBI) and Concussion in Children and Adolescents
A study testing Sample collection in people with Brain Injuries, Traumatic, run by Medicortex Finland Oy at 1 site in Finland.
Trial summary
The study will enroll children and adolescents (0 - 17 years) suspected of having concussion or mild traumatic brain injury (TBI). Samples of urine and saliva will be collected from the patients as well as from corresponding age- and gender-adjusted healthy controls. Read more about this study
- Who is it for?
- Ages 1 minute to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- Sample collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteFinland
- Study dates
- 14 May 2020to 14 Apr 2021
- Phase
- Interventional
- 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 1 minute to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The subject is suspected of having an isolated mild TBI (Glasgow Coma Score 13 - 15)
- No more that 6 hours elapsed from the incident of injury at the first sampling
- The patient is conscious
- Informed consent received from the legal guardian, and the subject him-/herself when literate and capable of understanding study measures
Who cannot join
- More than 6 hours elapsed from the injury, or unknown time of trauma
- Multi-trauma patient
- History of head injury, seizures or stroke within three preceding months
- Chronic neurodegenerative, metabolic or autoimmune disease
- Known existing neurological condition
Trial locations and contacts
1 site in 1 country.
About this study
The study will enroll children and adolescents (0 - 17 years) suspected of having concussion or mild traumatic brain injury (TBI). Samples of urine and saliva will be collected from the patients as well as from corresponding age- and gender-adjusted healthy controls.
Read the detailed description
The collected samples will be alienated to the Sponsor who will perform biochemical studies to identify and measure from the samples relative level of the brain injury-specific biomarkers.
- Conditions
- Brain Injuries, Traumatic
- Being tested
- Sample collection
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample collectionDiagnostic test
Samples of urine and saliva will be collected from participants using customary sample collection means.
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected brain injury | Experimental | This arm will consist of up to 30 pediatric patients who entered the Emergency Room and who are suspected of having mild traumatic brain injury. Two sample sets will be collected within the first 10 hours from the injury. Receives: Diagnostic Test: Sample collection |
| Healthy controls | Active comparator | This arm will consist of up to 30 healthy control subjects, the samples of whom will be compared to the samples of brain injury patients (Arm 1). One sample set will be collected from healthy children without any known brain injury. Receives: Diagnostic Test: Sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker levels
Quantitative measurement of the novel glycan-based biomarker using a lectin-binding assay
Measured: 12 months
Biomarker profiles
Characterization of different glycan structures present in the sample by mass spectrometry analysis
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start14 May 2020
- Primary completion14 Apr 2021
- Study completion14 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicortex Finland Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Satasairaala
- Responsible party
- Sponsor
- Investigators
- Sari Malmi, MD, Principal investigator, Satasairaala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288167
- Sponsor's protocol ID
- T257/2019
- Status last verified
- Apr 2021
- First submitted
- 13 Feb 2020
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data shall not be shared to outside of the study.
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biochemical Diagnostics of Mild Traumatic Brain Injury (TBI) and Concussion in Children and Adolescents
- ClinicalTrials.gov ID
- NCT04288167
- Acronym / sponsor ID
- T257/2019
- Conditions
- Brain Injuries, Traumatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Medicortex Finland OyIndustry (pharma, biotech, devices)
- Collaborators
- Satasairaala
- Study start
- 14 May 2020 (actual)
- Primary completion
- 14 Apr 2021 (actual)
- Study completion
- 14 Apr 2021 (actual)
- First posted
- 28 Feb 2020 (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 study will enroll children and adolescents (0 - 17 years) suspected of having concussion or mild traumatic brain injury (TBI). Samples of urine and saliva will be collected from the patients as well as from corresponding age- and gender-adjusted healthy controls.
Detailed description
The collected samples will be alienated to the Sponsor who will perform biochemical studies to identify and measure from the samples relative level of the brain injury-specific biomarkers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected brain injury | Experimental | Diagnostic Test: Sample collectionThis arm will consist of up to 30 pediatric patients who entered the Emergency Room and who are suspected of having mild traumatic brain injury. Two sample sets will be collected within the first 10 hours from the injury. |
| Healthy controls | Active comparator | Diagnostic Test: Sample collectionThis arm will consist of up to 30 healthy control subjects, the samples of whom will be compared to the samples of brain injury patients (Arm 1). One sample set will be collected from healthy children without any known brain injury. |
Who may qualify
- Ages
- 1 minute to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The subject is suspected of having an isolated mild TBI (Glasgow Coma Score 13 - 15)
- No more that 6 hours elapsed from the incident of injury at the first sampling
- The patient is conscious
- Informed consent received from the legal guardian, and the subject him-/herself when literate and capable of understanding study measures
Key exclusion criteria (5 listed)
- More than 6 hours elapsed from the injury, or unknown time of trauma
- Multi-trauma patient
- History of head injury, seizures or stroke within three preceding months
- Chronic neurodegenerative, metabolic or autoimmune disease
- Known existing neurological condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sample collectionSamples of urine and saliva will be collected from participants using customary sample collection means. | Diagnostic test | Healthy controls, Patients with suspected brain injury |
Primary outcome
Biomarker levels
Time frame: 12 months
Quantitative measurement of the novel glycan-based biomarker using a lectin-binding assay
Biomarker profiles
Time frame: 12 months
Characterization of different glycan structures present in the sample by mass spectrometry analysis
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 3 May 2021.
- Individual participant dataSharing planned: No. Individual participant data shall not be shared to outside of the study.
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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.
Sari Malmi, MD principal investigator
Satasairaala
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sample collection in people with Brain Injuries, Traumatic, run by Medicortex Finland Oy at 1 site in Finland.
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 4 inclusion and 5 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 3 May 2021. 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 Finland. 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?
Biomarker levels (time frame: 12 months). 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 3 May 2021.