Clinical trial NCT02992327: Biomarker Levels as A Predictor of Concussion Severity OUTcomes (BlacOut)
Official title: Biomarker Levels as A Predictor of Concussion Severity OUTcomes (BlacOut)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Concussion, Mild
Neurocognitive Dysfunction
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
First posted: 2016-12-14
Enrollment: 100
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal volunteers presenting to the emergency department with a diagnosis of concussion.

Brief summary: 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.

Detailed description: The novel aspect of the proposed study relates to the fact that the STNF protein is the first evidence that a biomarker in human blood can help clinicians determine a specific patient's clinical outcome from a concussion. This in turn will help clinicians and concussion specialists with designing treatment protocols very early after the initial injury that could have significant impacts on the health of the patient.

This study has several important benefits to the scientific community. Concussion treatment today is uncertain. Some patients are back to baseline one or two days post injury whereas other patients are experiencing debilitating symptoms for months after the injury. Until the patient begins to report symptoms, the course of treatment cannot be determined. Other biomarkers for concussion diagnosis are being evaluated, but this is the first biomarker to show promise for patient stratification and earlier intervention and treatment for the subset of cases at high risk of suffering brain damage and persisting dysfunction after concussion. Currently, no prognostic method exists for identifying at an early and potentially treatable stage the small subset of concussion sufferers at risk of diffuse axonal injury and persisting brain functional impairment.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Results of neurocognitive testing
timeFrame: 30 days from index injury
measure: Symptom severity
timeFrame: 30 days post injury
Secondary outcomes:
measure: SNTF plasma and serum levels
timeFrame: 24 hours, 30 days and 90 days post injury
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
Study officials:
affiliation: Regions Hospital
name: Sandi Wewerka, MPH
role: PRINCIPAL_INVESTIGATOR
References: