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MIND (Management of Traumatic Brain Injury Diagnosis)

Sponsor
Abbott Diagnostics Division (Industry)
Overall Status
Completed
CT.gov ID
NCT02262286
Collaborator
(none)
239
Enrollment
1
Location
24
Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    239 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Study to Procure Human Specimens for Use in the Diagnosis and Management of Traumatic Brain Injury and Other Related Conditions
    Study Start Date :
    Sep 1, 2014
    Actual Primary Completion Date :
    Sep 1, 2016
    Actual Study Completion Date :
    Sep 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Brain Injury

    Brain Injury
    Control

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

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Klinikum rechts der Isar Munich Germany 81675

    Sponsors and Collaborators

    • Abbott Diagnostics Division

    Investigators

    • Principal Investigator: Peter Biberthaler, MD/PHD, Klinikum reichs der Isar

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abbott Diagnostics Division
    ClinicalTrials.gov Identifier:
    NCT02262286
    Other Study ID Numbers:
    • 9GP-02-10DELK14
    First Posted:
    Oct 13, 2014
    Last Update Posted:
    Feb 10, 2017
    Last Verified:
    Feb 1, 2017
    Keywords provided by Abbott Diagnostics Division
    Brain Injury
    Additional relevant MeSH terms:
    Brain Injuries
    Brain Injuries, Traumatic
    Wounds and Injuries

    Study Results

    No Results Posted as of Feb 10, 2017