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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02262286
Other study ID # 9GP-02-10DELK14
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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