MIND (Management of Traumatic Brain Injury Diagnosis)

N/ACompletedNCT02262286

Abbott Diagnostics Division239 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

239

Conditions

Brain Injury

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Klinikum rechts der Isar

Munich, Germany

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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