Traumatic Brain InjuryNCT03306563
Rapid Biochemical Diagnostics of Traumatic Brain Injury
A study testing Sample collection in people with Traumatic Brain Injury and Concussion, Mild, run by Medicortex Finland Oy at 3 sites in Finland.
Trial summary
The objective of the study is to confirm the clinical relevance of the novel biomarker for traumatic brain injury (TBI) detection. Samples of blood, urine and saliva will be collected from a) patients with suspected TBI (isolated), b) patients with orthopedic injury, and c) healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Concussion, Mild, Bone Fracture
- What is being tested?
- Sample collection
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 3 sitesFinland
- Study dates
- 28 Dec 2017to 7 Jun 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed written informed consent form (Finnish or Swedish)
- Age 18 - 75 years (Male or Female)
- For patients with a suspected TBI: Presenting to the ED within 4 hours after the injury, and no orthopedic trauma (fractures of long bones) present.
- For patients with a suspected TBI: Deemed to have a computed tomography (CT) scan as a part of their intended medical diagnosis and treatment.
- For patients with orthopedic injuries: Presentation with a bone fracture, but without any suspicion of any TBI.
Who cannot join
- Unknown time of trauma (uncertainty more than 1 hour).
- More than 4 hours from the injury.
- Known or suspected pre-existing neurological condition that can cause the observed symptoms
- For women of child-bearing age: known to be or suspected to be pregnant.
- History of seizures within the last three months.
- History of infection with HIV or hepatitis B, or diagnosed to be positive in the concomitant screening.
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- Patients where the presence of TBI cannot be assessed reliably because of alcohol or drugs, especially current use of anti-psychotic or anxiolytic medication.
- History of stroke within three months.
- The subject has a chronic neurodegenerative, metabolic (e.g. diabetes), or an autoimmune disease.
Trial locations and contacts
3 sites in 1 country.
Finland3 sites
Satakunta Central Hospital
Pori, 28500
Turku University Hospital (Tyks)
Turku
Vaasa Central Hospital
Vaasa, 65130
About this study
The objective of the study is to confirm the clinical relevance of the novel biomarker for traumatic brain injury (TBI) detection. Samples of blood, urine and saliva will be collected from a) patients with suspected TBI (isolated), b) patients with orthopedic injury, and c) healthy controls. The sponsor will do biochemical investigations for the samples to evaluate the presence, level and structure of the targeted biomarker.
Read the detailed description
The study will analyze and compare the levels of certain biomolecules and cellular degradation products which are released upon a brain injury and which become detectable in the body fluids. Patients with a traumatic brain injury are supposed to express these biomarkers in their body fluids while orthopedic trauma patients and healthy controls are supposed to be undetectable with respect to these biomolecules. The study is a case-control study where the study subjects with a property (injured) are compared to subjects without the property (healthy). The brain injury patient group will consist of subjects who entered the Emergency Department of the hospital with a suspected TBI. The orthopedic patient group will consists of patients who were admitted with a bone fracture in the limbs, but without a suspected TBI. The control group will consist of healthy subjects who will be recruited to the study by the activities of the study personnel.
The entire study is split into two successive parts. In the first Part I, 18 - 24 subjects will be recruited in each group. In the second part, the number of the patients with suspected TBI will be added to up to 100 in order to receive an adequate number of samples and to gain sufficient statistical significance between the brain injury severities and in successive sampling time points.
The collected samples and relevant clinical data of each subject will be supplied to the sponsor who will perform to the samples 1) Biochemical analysis for the presence and level of the biomarker, and 2) Biomarker profiling and structure analysis by LC/MS.
- Conditions
- Traumatic Brain Injury, Concussion, Mild, Bone Fracture
- Being tested
- Sample collection
- Keywords
- TBI, Mild traumatic brain injury, Concussion, Diagnostics, Rapid test, Traumatic Brain Injury, mTBI
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample collectionDiagnostic test
Samples of blood, urine and saliva will be collected at up to five successive time points.
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected TBI | Experimental | The group will consist of patients who have arrived in the hospital with head injury and suspected isolated TBI. Sample collection (up to five times) and assessment of neurological status. Receives: Diagnostic Test: Sample collection |
| Orthopedic patients | Active comparator | The group will consist of patients with orthopedic injury, but without a head injury and suspected TBI. Sample collection (once). Receives: Diagnostic Test: Sample collection |
| Controls | Sham comparator | The group will consist of healthy controls who do not have a recent trauma history. Sample collection (once). Receives: Diagnostic Test: Sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker level
Analytical measurement of the biomarker level. (biodegradation glycans detected by HPLC-MS).
Measured: One year (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start28 Dec 2017
- Primary completion23 Jan 2019
- Study completion7 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Total of 160 patients Phase 2a, 60 patients divided in three groups with TBI, orthopedic injury, and healthy volunteers (controls). Phase 2b: 100 patients with concussion and mild traumatic brain injury.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicortex Finland Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mårten Kvist, MD/PhD, Study director, Medicortex Finland Oy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306563
- Sponsor's protocol ID
- T213/2017
- Status last verified
- Jun 2021
- First submitted
- 29 Sep 2017
- Last updated
- 8 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Biochemical Diagnostics of Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03306563
- Acronym / sponsor ID
- T213/2017
- Conditions
- Traumatic Brain Injury, Concussion, Mild, Bone Fracture
- Keywords
- TBI, Mild traumatic brain injury, Concussion, Diagnostics, Rapid test, Traumatic Brain Injury, mTBI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Medicortex Finland OyIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2017 (actual)
- Primary completion
- 23 Jan 2019 (actual)
- Study completion
- 7 Jun 2021 (actual)
- First posted
- 11 Oct 2017 (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 objective of the study is to confirm the clinical relevance of the novel biomarker for traumatic brain injury (TBI) detection. Samples of blood, urine and saliva will be collected from a) patients with suspected TBI (isolated), b) patients with orthopedic injury, and c) healthy controls. The sponsor will do biochemical investigations for the samples to evaluate the presence, level and structure of the targeted biomarker.
Detailed description
The study will analyze and compare the levels of certain biomolecules and cellular degradation products which are released upon a brain injury and which become detectable in the body fluids. Patients with a traumatic brain injury are supposed to express these biomarkers in their body fluids while orthopedic trauma patients and healthy controls are supposed to be undetectable with respect to these biomolecules. The study is a case-control study where the study subjects with a property (injured) are compared to subjects without the property (healthy). The brain injury patient group will consist of subjects who entered the Emergency Department of the hospital with a suspected TBI. The orthopedic patient group will consists of patients who were admitted with a bone fracture in the limbs, but without a suspected TBI. The control group will consist of healthy subjects who will be recruited to the study by the activities of the study personnel.
The entire study is split into two successive parts. In the first Part I, 18 - 24 subjects will be recruited in each group. In the second part, the number of the patients with suspected TBI will be added to up to 100 in order to receive an adequate number of samples and to gain sufficient statistical significance between the brain injury severities and in successive sampling time points.
The collected samples and relevant clinical data of each subject will be supplied to the sponsor who will perform to the samples 1) Biochemical analysis for the presence and level of the biomarker, and 2) Biomarker profiling and structure analysis by LC/MS.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Total of 160 patients Phase 2a, 60 patients divided in three groups with TBI, orthopedic injury, and healthy volunteers (controls). Phase 2b: 100 patients with concussion and mild traumatic brain injury.
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected TBI | Experimental | Diagnostic Test: Sample collectionThe group will consist of patients who have arrived in the hospital with head injury and suspected isolated TBI. Sample collection (up to five times) and assessment of neurological status. |
| Orthopedic patients | Active comparator | Diagnostic Test: Sample collectionThe group will consist of patients with orthopedic injury, but without a head injury and suspected TBI. Sample collection (once). |
| Controls | Sham comparator | Diagnostic Test: Sample collectionThe group will consist of healthy controls who do not have a recent trauma history. Sample collection (once). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed written informed consent form (Finnish or Swedish)
- Age 18 - 75 years (Male or Female)
- For patients with a suspected TBI: Presenting to the ED within 4 hours after the injury, and no orthopedic trauma (fractures of long bones) present.
- For patients with a suspected TBI: Deemed to have a computed tomography (CT) scan as a part of their intended medical diagnosis and treatment.
- For patients with orthopedic injuries: Presentation with a bone fracture, but without any suspicion of any TBI.
Key exclusion criteria (9 listed)
- Unknown time of trauma (uncertainty more than 1 hour).
- More than 4 hours from the injury.
- Known or suspected pre-existing neurological condition that can cause the observed symptoms
- For women of child-bearing age: known to be or suspected to be pregnant.
- History of seizures within the last three months.
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 blood, urine and saliva will be collected at up to five successive time points. | Diagnostic test | Controls, Orthopedic patients, Patients with suspected TBI |
Primary outcome
Biomarker level
Time frame: One year (1 year)
Analytical measurement of the biomarker level. (biodegradation glycans detected by HPLC-MS).
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 8 Jun 2021.
- Individual participant dataSharing planned: No. Data will not be shared with other researchers.
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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.
Mårten Kvist, MD/PhD study director
Medicortex Finland Oy
3 sites 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 Traumatic Brain Injury and Concussion, Mild, run by Medicortex Finland Oy at 3 sites 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 5 inclusion and 9 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 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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 level (time frame: One year (1 year)). 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 8 Jun 2021.