MIND (Management of Traumatic Brain Injury Diagnosis)

Study to Procure Human Specimens for Use in the Diagnosis and Management of Traumatic Brain Injury and Other Related Conditions

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02262286

Acronym

MIND

Enrollment

239

Registered

2014-10-13

Start date

2014-09-30

Completion date

2016-09-30

Last updated

2017-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injury

Keywords

Brain Injury

Brief summary

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* 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

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

Design outcomes

Primary

Measure	Time frame	Description
Measurement of specific biomarker(s) for brain injury	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.

Countries

Germany

Outcome results