Concussion, MildBlacOutNCT02992327
Biomarker Levels as A Predictor of Concussion Severity OUTcomes (BlacOut)
An observational study of Concussion, Mild and Neurocognitive Dysfunction, run by HealthPartners Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Concussion, Mild, Neurocognitive Dysfunction
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2015to 6 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Normal volunteers presenting to the emergency department with a diagnosis of concussion.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Concussion, Mild, Neurocognitive Dysfunction
- Medical subject headings
- Brain Concussion, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Patients age ≥ 8 years of age with a GCS >13 presenting to the emergency department with a diagnosis of concussion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of neurocognitive testing
Neurocognitive testing a 30 days post injury to assess symptom severity
Measured: 30 days from index injury
Symptom severity
assay level of SNTF biomarker
Measured: 30 days post injury
Secondary outcomes (1)
SNTF plasma and serum levels
SNTF plasma and serum levels measured with 24 hours of injury, at 30 days, at 90 days.
Measured: 24 hours, 30 days and 90 days post injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study start30 Aug 2015
- Primary completion6 Aug 2018
- Study completion6 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Sandi Wewerka, MPH, Principal investigator, Regions Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992327
- Sponsor's protocol ID
- A15-085
- Acronym
- BlacOut
- Status last verified
- Sep 2018
- First submitted
- 12 Dec 2016
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Levels as A Predictor of Concussion Severity OUTcomes (BlacOut)
- ClinicalTrials.gov ID
- NCT02992327
- Acronym / sponsor ID
- BlacOut / A15-085
- Conditions
- Concussion, Mild, Neurocognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- 30 Aug 2015 (actual)
- Primary completion
- 6 Aug 2018 (actual)
- Study completion
- 6 Aug 2018 (actual)
- First posted
- 14 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | –Patients age ≥ 8 years of age with a GCS >13 presenting to the emergency department with a diagnosis of concussion. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Normal volunteers presenting to the emergency department with a diagnosis of concussion.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Results of neurocognitive testing
Time frame: 30 days from index injury
Neurocognitive testing a 30 days post injury to assess symptom severity
Symptom severity
Time frame: 30 days post injury
assay level of SNTF biomarker
1 secondary outcome
SNTF plasma and serum levels
Time frame: 24 hours, 30 days and 90 days post injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Individual participant dataSharing planned: No. There is no plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandi Wewerka, MPH principal investigator
Regions Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Concussion, Mild and Neurocognitive Dysfunction, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Results of neurocognitive testing (time frame: 30 days from index injury). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018.