Biomarker Levels as A Predictor of Concussion Severity OUTcomes (BlacOut)

NCT02992327 | Completed

• 1 other identifier: A15-085
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion, Mild; Neurocognitive Dysfunction

Outcome Measures

Primary Outcomes (2)

• Results of neurocognitive testing

  Neurocognitive testing a 30 days post injury to assess symptom severity

  30 days from index injury

• Symptom severity

  assay level of SNTF biomarker

  30 days post injury

Secondary Outcomes (1)

• SNTF plasma and serum levels

  24 hours, 30 days and 90 days post injury

Study Arms (1)

Cohort

Patients age ≥ 8 years of age with a GCS \>13 presenting to the emergency department with a diagnosis of concussion.

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Normal volunteers presenting to the emergency department with a diagnosis of concussion.

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

Sponsors & Collaborators

• HealthPartners Institute: lead
• University of Pennsylvania: collaborator

Study Sites (1)

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The laboratory has developed and characterized extensively an antibody that reacts with the SNTF (structural brain protein calpain-cleaved αII-spectrin N-terminal fragment) fragment of aII-spectrin but does not recognize either the intact aII-spectrin or any other fragment of it. The laboratory has used this antibody as a foundation for an ultrasensitive, specific, standardized sandwich immunoassay for measuring trace quantities of SNTF in human serum and plasma in the acute period after brain injury19,27 The method employs state-of-the-art electrochemiluminescence chemistry that is widely used in the clinical diagnostics arena for measuring protein biomarkers in biological fluids.

MeSH Terms

Conditions

Brain Concussion; Cognition Disorders

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sandi Wewerka, MPH

  Regions Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: December 14, 2016
• Study Start: August 30, 2015
• Primary Completion: August 6, 2018
• Study Completion: August 6, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)