Brain Injury Clinical Trial
— MINDOfficial title:
Study to Procure Human Specimens for Use in the Diagnosis and Management of Traumatic Brain Injury and Other Related Conditions
Verified date | February 2017 |
Source | Abbott Diagnostics Division |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Procure blood specimens from individuals presenting to the emergency department with suspected brain injury.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Klinikum rechts der Isar | Munich |
Lead Sponsor | Collaborator |
---|---|
Abbott Diagnostics Division |
Germany,
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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