Brain InjuryMINDNCT02262286
MIND (Management of Traumatic Brain Injury Diagnosis)
An observational study of Brain Injury, run by Abbott Diagnostics Division at 1 site in Germany.
Trial summary
Procure blood specimens from individuals presenting to the emergency department with suspected brain injury. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Injury
- How many people
- 239 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2014to Sep 2016
- 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: Individuals presenting to the ED within 6 hours of experiencing a head trauma, or bone fractions only.
Who may be able to join
- Informed Consent Form Signed
- 18 years of age or older
- For women of child-bearing age: Not known to be pregnant AND
- Head Trauma within 6 hours of ED presentation with Glasgow Coma Scores from 3-8 (Severe Injury), 9-13 (Moderate Injury), or 14-15 (Mild Injury); OR
- Head trauma within 6 hours of ED presentation with Glasgow Coma Score of 15; OR
- Bone fracture or poly-traumas, both with no head trauma
Who cannot join
- Known pre-existing neurological condition that causes observed symptoms
- Recent history of head injury or seizures (within 1 year of current ED presentation)
- Prisoner
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Procure Human Specimens for Use in the Diagnosis and Management of Traumatic Brain Injury and Other Related Conditions
Procure blood specimens from individuals presenting to the emergency department with suspected brain injury.
- Conditions
- Brain Injury
- Keywords
- Brain Injury
- Medical subject headings
- Brain Injuries
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 |
|---|---|---|
| Brain Injury | Brain Injury | |
| Control | Healthy, or Head Trauma, or Orthopedic Trauma, or Poly-Trauma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of specific biomarker(s) for brain injury
Measurement of specific biomarkers to detect brain injury (mild to severe). using 2 or more serial draws from subjects. The biomarkers tested will include established biomarkers s100B, GFAP (Glial Fibrillary Acidic Protein) and also proprietary novel protein and lipid biomarkers that are being studied in discovery research.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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-control
- Time perspective
- Prospective
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Diagnostics Division
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Biberthaler, MD/PHD, Principal investigator, Klinikum reichs der Isar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262286
- Sponsor's protocol ID
- 9GP-02-10DELK14
- Acronym
- MIND
- Status last verified
- Feb 2017
- First submitted
- 23 Sep 2014
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Procure Human Specimens for Use in the Diagnosis and Management of Traumatic Brain Injury and Other Related Conditions
- ClinicalTrials.gov ID
- NCT02262286
- Acronym / sponsor ID
- MIND / 9GP-02-10DELK14
- Conditions
- Brain Injury
- Keywords
- Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Abbott Diagnostics DivisionIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 13 Oct 2014 (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.
Procure blood specimens from individuals presenting to the emergency department with suspected brain injury.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brain Injury | – | –Brain Injury |
| Control | – | –Healthy, or Head Trauma, or Orthopedic Trauma, or Poly-Trauma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals presenting to the ED within 6 hours of experiencing a head trauma, or bone fractions only.
Key inclusion criteria (6 listed)
- Informed Consent Form Signed
- 18 years of age or older
- For women of child-bearing age: Not known to be pregnant AND
- Head Trauma within 6 hours of ED presentation with Glasgow Coma Scores from 3-8 (Severe Injury), 9-13 (Moderate Injury), or 14-15 (Mild Injury); OR
- Head trauma within 6 hours of ED presentation with Glasgow Coma Score of 15; OR
Key exclusion criteria (3 listed)
- Known pre-existing neurological condition that causes observed symptoms
- Recent history of head injury or seizures (within 1 year of current ED presentation)
- Prisoner
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
Measurement of specific biomarker(s) for brain injury
Time frame: 48 hours
Measurement of specific biomarkers to detect brain injury (mild to severe). using 2 or more serial draws from subjects. The biomarkers tested will include established biomarkers s100B, GFAP (Glial Fibrillary Acidic Protein) and also proprietary novel protein and lipid biomarkers that are being studied in discovery research.
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 10 Feb 2017.
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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.
Peter Biberthaler, MD/PHD principal investigator
Klinikum reichs der Isar
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 Brain Injury, run by Abbott Diagnostics Division at 1 site in Germany.
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 6 inclusion and 3 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 10 Feb 2017. 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 Germany. 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?
Measurement of specific biomarker(s) for brain injury (time frame: 48 hours). 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 10 Feb 2017.