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

Concussion, Mild Clinical Trial

— BlacOut  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02992327
• Other study ID #: A15-085
• Status: Completed
• Start date: August 30, 2015
• Est. completion date: August 6, 2018

Study information

• Verified date: September 2018
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 6, 2018
• Est. primary completion date: August 6, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Cognitive Dysfunction
• Concussion, Mild
• Neurocognitive Dysfunction

Locations

Country	Name	City	State
United States	Regions Hospital	Saint Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
HealthPartners Institute	University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Results of neurocognitive testing	Neurocognitive testing a 30 days post injury to assess symptom severity	30 days from index injury
Primary	Symptom severity	assay level of SNTF biomarker	30 days post injury
Secondary	SNTF plasma and serum levels	SNTF plasma and serum levels measured with 24 hours of injury, at 30 days, at 90 days.	24 hours, 30 days and 90 days post injury