MIND (Management of Traumatic Brain Injury Diagnosis)

Brain Injury Clinical Trial

— MIND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02262286
• Other study ID #: 9GP-02-10DELK14
• Status: Completed
• Phase: N/A
• First received: September 23, 2014
• Last updated: February 8, 2017
• Start date: September 2014
• Est. completion date: September 2016

Study information

• Verified date: February 2017
• Source: Abbott Diagnostics Division
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury
• Wounds and Injuries

Locations

Country	Name	City	State
Germany	Klinikum rechts der Isar	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Diagnostics Division

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	48 hours