MIND (Management of Traumatic Brain Injury Diagnosis)

Completed

• Conditions: Brain Injury

• Registration Number: NCT02262286
• Lead Sponsor: Abbott Diagnostics Division

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-23
• Study First Submitted QC: 2014-10-08
• Study First Posted: 2014-10-13
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-08
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Klinikum rechts der Isar; 🇩🇪 Munich, Germany