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OpenTrials
Completed

NCT Number: NCT02262286

MIND (Management of Traumatic Brain Injury Diagnosis)

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

Completed

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Key information

Conditions

Brain Injury Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum rechts der Isar

Munich, 81675, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Measurement of specific biomarker(s) for brain injury

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Abbott Diagnostics Division

Industry

Registry information

Official study title

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

Acronym: MIND

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 13, 2014
Registry last updated
Feb 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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