MIND (Management of Traumatic Brain Injury Diagnosis)

NCT ID: NCT02262286

Last Updated: 2017-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

239 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-09-30

Brief Summary

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

Detailed Description

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Conditions

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Brain Injury

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Brain Injury

Brain Injury

No interventions assigned to this group

Control

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott Diagnostics Division

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Biberthaler, MD/PHD

Role: PRINCIPAL_INVESTIGATOR

Klinikum reichs der Isar

Locations

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Klinikum rechts der Isar

Munich, , Germany

Site Status

Countries

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Germany

Other Identifiers

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9GP-02-10DELK14

Identifier Type: -

Identifier Source: org_study_id

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