Biomarker Levels as A Predictor of Concussion Severity OUTcomes (BlacOut)
Completed
Conditions studied: Concussion, Mild, Neurocognitive Dysfunction
In brief
The overall research aim of this pilot study is to determine if the structural brain protein calpain-cleaved αII-spectrin N-terminal fragment (SNTF) can be used as a blood biomarker to accurately identify patients who will have more severe symptoms and reduced neurocognitive functioning after sustaining a concussion. Concussion is also referred to as mild traumatic brain injury (mTBI) in the literature. Both terms will be used interchangeably throughout this application.
Key facts
- Study ID
- NCT02992327
- Run by
- HealthPartners Institute
- People needed
- 100
- Starts
- 2015-08-30
- Expected to finish
- 2018-08-06
- Last updated by the study team
- 2018-09-07
Who can join
Age: 8 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Patient is ≥ 8 years old 2. Ability to enroll within 24 hours of injury 3. Ability to follow-up with patient 30 days following enrollment 4. Concussion by history or physical examination (head injury and symptoms such as headache, nausea, vomiting, dizziness, fatigue, irritability, or poor concentration following the injury) 5. GCS ≥ 13 6. Abbreviated Injury Score (AIS) ≤ 3 7. Plan to be discharged from the emergency department to the outpatient observation unit or to home
You may not qualify if…
- Non-English speaking 2. Trauma Team Activation (TTA) 3. Abnormal acute intracranial CT/MRI findings 4. Blood alcohol level (> 200 mg/dL) 5. Previous head injury within 30 days of enrollment 6. Pre-existing neurologic disorder associated with cerebral dysfunction and/or cognitive deficit (such as dementia, cerebral palsy, mental retardation, epilepsy, dyslexia) 7. Pre-existing psychiatric disorder (such as bipolar disorder and schizophrenia) as indicated by medical history 8. Planned admission to a hospital inpatient unit
Where it is running
- Regions Hospital — Saint Paul, Minnesota, United States
Full record on ClinicalTrials.gov
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