ClinicalTrials.gg
CompletedNCT02262286MINDUpdated Feb 10, 2017

MIND (Management of Traumatic Brain Injury Diagnosis)

An observational study in Brain Injury, sponsored by Abbott Diagnostics Division. Completed at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-10.

Sponsored by Abbott Diagnostics Division (part of Abbott) · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
239
Ages
18 Years and older
Sex
All
01

Study summary

Procure blood specimens from individuals presenting to the emergency department with suspected brain injury.

02

Conditions studied

  • Brain Injury

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Keywords

  • Brain Injury
03

In context

Brain Injuries

946 studies on the registry are indexed under Brain Injuries; 235 are open to participants now.

This study's enrollment of 239 is above the median of 100 across 302 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Abbott Diagnostics Division is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Individuals presenting to the ED within 6 hours of experiencing a head trauma, or bone fractions only.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Known pre-existing neurological condition that causes observed symptoms
  • Recent history of head injury or seizures (within 1 year of current ED presentation)
  • Prisoner
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
239 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Brain Injury

    Brain Injury

  • Control

    Healthy, or Head Trauma, or Orthopedic Trauma, or Poly-Trauma

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 48 hours

07

Study locations

1 site
  • Klinikum rechts der Isar
    Munich, 81675, Germany
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2014, a primary completion of Sep 2016 and a completion of Sep 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 23, 2014
First posted
Oct 13, 2014
Start
Sep 2014
Primary completionActual
Sep 2016
CompletionActual
Sep 2016
Last update
Feb 10, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02262286
Responsible party
Sponsor
First posted
Oct 13, 2014
Start date
Sep 2014
Primary completion
Sep 2016
Completion
Sep 2016
Last update
Feb 10, 2017

Study contacts

Peter Biberthaler, MD/PHD
principal investigator · Klinikum reichs der Isar

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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