Traumatic Brain InjuryNCT02836951
Rapid Diagnostics for Traumatic Brain Injury (TBI)
An observational study of Traumatic Brain Injury, run by Medicortex Finland Oy at 1 site in Finland.
Trial summary
Novel biomarkers of traumatic brain injury (TBI) have been discovered in laboratory animal models. The objective of this study is to find whether similar markers are detectable in the body fluids of human subjects that have sustained a TBI. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Withdrawal of blood
- How many people
- 24 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2016to 31 Jan 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population will include patients that are hospitalized due to a suspected traumatic brain injury. Identical number of healthy volunteers will serve as controls.
Who may be able to join
- Patient is hospitalized because of a head trauma and suspected TBI.
- Age 18 or above. The subject (including the control subjects) must be an independent adult who is not under guardianship.
- The patient, or the next of kin in the case of an incompetent person, has signed the Informed consent. This concerns the control subjects, too.
- The samples can be collected during regular office hours.
- The patient needs lumbar puncture for treatment reasons. This is not a limiting criterion however. If it is difficult to find an adequate number of patients for lumbar puncture, CSF samples of some patients can be omitted after the study coordinator's consideration.
Who cannot join
- The subject has been found positive for HIV or hepatitis-B in the involved laboratory studies.
- The subject has a chronic mental disorder which is mentioned on the sickness insurance card.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rapid Chemical Diagnostics of Brain Injuries
Novel biomarkers of traumatic brain injury (TBI) have been discovered in laboratory animal models. The objective of this study is to find whether similar markers are detectable in the body fluids of human subjects that have sustained a TBI.
Read the detailed description
Staff of the Neurosurgical ward is asked to report to the study coordinator all patients who are hospitalized due to a suspected brain injury. After an informed consent is received, the patient has been enrolled in the study and sample collection can be started. Plasma samples are taken by the TYKSlab personnel, and the other samples by the nurses in the Neurosurgical ward. The sampling will be organized so that all the samples from a patient are preferably collected at one event. Samples will stored in the TYKSlab at the temperature of -70 °C. Collection of a sufficient number of samples (patients) will take a few months, and subsequent analysis by the Sponsor a few months. All the activities will be done during the years 2016 to 2017.
When the samples of 24 subjects have been collected, they will be transferred to the Sponsor who will ship them further to the sub-contractors. The results received from the research laboratories will be evaluated by the scientist team at Medicortex Finland Oy. The results will be published in a scientific journal, when considered to be of high enough quality and impact.
- Conditions
- Traumatic Brain Injury
- Being tested
- Withdrawal of blood
- 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.
Withdrawal of bloodOther
Withdrawal of blood
| Study group | Role | What they receive |
|---|---|---|
| Patient | This group consists of patients that are hospitalized due to a head injury. Samples of blood, urine and plasma will taken from these subjects and the fluids will be analyzed for novel biomarkers using a biochemical assay. Receives: Other: Withdrawal of blood | |
| Healthy controls | This group consists of healthy volunteers. Samples of blood, urine and plasma will taken from these subjects and the fluids will be analyzed for novel biomarkers using a biochemical assay. Receives: Other: Withdrawal of blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of lectin-complexes in patients with TBI
There is a difference in the intensity of immuno-fluorescence readings between TBI patients and healthy controls. Different lectin bound complexes will be studied in body fluid samples collected from the patients (the trial is not following the patients nor is it intended to evaluate clinical outcome).
Measured: Two years
Characterization of molecule structure of lectin-complexes
Molecular characterization of lectin-complexes by HPLC (high performance liquid chromatography) and MS (mass spectrometry) analysis. Samples retrieved from the patients are being analyzed comparing head injured to healthy controls. No follow-up of the patients and no clinical evaluation.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startSep 2016
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicortex Finland Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Turku University Hospital
- Responsible party
- Sponsor
- Investigators
- Jaakko Rinne, Professor, Principal investigator, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836951
- Sponsor's protocol ID
- T129/2016
- Status last verified
- Sep 2020
- First submitted
- 15 Jul 2016
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Chemical Diagnostics of Brain Injuries
- ClinicalTrials.gov ID
- NCT02836951
- Acronym / sponsor ID
- T129/2016
- Conditions
- Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Medicortex Finland OyIndustry (pharma, biotech, devices)
- Collaborators
- Turku University Hospital
- Study start
- Sep 2016 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 19 Jul 2016 (estimated)
- 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.
Novel biomarkers of traumatic brain injury (TBI) have been discovered in laboratory animal models. The objective of this study is to find whether similar markers are detectable in the body fluids of human subjects that have sustained a TBI.
Detailed description
Staff of the Neurosurgical ward is asked to report to the study coordinator all patients who are hospitalized due to a suspected brain injury. After an informed consent is received, the patient has been enrolled in the study and sample collection can be started. Plasma samples are taken by the TYKSlab personnel, and the other samples by the nurses in the Neurosurgical ward. The sampling will be organized so that all the samples from a patient are preferably collected at one event. Samples will stored in the TYKSlab at the temperature of -70 °C. Collection of a sufficient number of samples (patients) will take a few months, and subsequent analysis by the Sponsor a few months. All the activities will be done during the years 2016 to 2017.
When the samples of 24 subjects have been collected, they will be transferred to the Sponsor who will ship them further to the sub-contractors. The results received from the research laboratories will be evaluated by the scientist team at Medicortex Finland Oy. The results will be published in a scientific journal, when considered to be of high enough quality and impact.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Other: Withdrawal of bloodThis group consists of patients that are hospitalized due to a head injury. Samples of blood, urine and plasma will taken from these subjects and the fluids will be analyzed for novel biomarkers using a biochemical assay. |
| Healthy controls | – | Other: Withdrawal of bloodThis group consists of healthy volunteers. Samples of blood, urine and plasma will taken from these subjects and the fluids will be analyzed for novel biomarkers using a biochemical assay. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will include patients that are hospitalized due to a suspected traumatic brain injury. Identical number of healthy volunteers will serve as controls.
Key inclusion criteria (5 listed)
- Patient is hospitalized because of a head trauma and suspected TBI.
- Age 18 or above. The subject (including the control subjects) must be an independent adult who is not under guardianship.
- The patient, or the next of kin in the case of an incompetent person, has signed the Informed consent. This concerns the control subjects, too.
- The samples can be collected during regular office hours.
- The patient needs lumbar puncture for treatment reasons. This is not a limiting criterion however. If it is difficult to find an adequate number of patients for lumbar puncture, CSF samples of some patients can be omitted after the study coordinator's consideration.
Key exclusion criteria (2 listed)
- The subject has been found positive for HIV or hepatitis-B in the involved laboratory studies.
- The subject has a chronic mental disorder which is mentioned on the sickness insurance card.
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 |
|---|---|---|
| Withdrawal of bloodWithdrawal of blood | Other | Healthy controls, Patient |
Primary outcome
Presence of lectin-complexes in patients with TBI
Time frame: Two years
There is a difference in the intensity of immuno-fluorescence readings between TBI patients and healthy controls. Different lectin bound complexes will be studied in body fluid samples collected from the patients (the trial is not following the patients nor is it intended to evaluate clinical outcome).
Characterization of molecule structure of lectin-complexes
Time frame: Two years
Molecular characterization of lectin-complexes by HPLC (high performance liquid chromatography) and MS (mass spectrometry) analysis. Samples retrieved from the patients are being analyzed comparing head injured to healthy controls. No follow-up of the patients and no clinical evaluation.
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 Sep 2020.
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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.
Jaakko Rinne, Professor principal investigator
University of Turku
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 Traumatic Brain Injury, 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 5 inclusion and 2 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 Sep 2020. 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?
Presence of lectin-complexes in patients with TBI (time frame: Two years). 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 Sep 2020.