HEAD Injury Serum Markers and Multi-modalities for Assessing Response to Trauma
NCT ID: NCT04423198
Last Updated: 2021-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2000 participants
OBSERVATIONAL
2020-12-31
2021-12-31
Brief Summary
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Detailed Description
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This is an observational study with an expectation of enrolling up to 2000 subjects. These subjects will include the intended use population, subjects presenting to the Emergency Department or Urgent Care with a blunt head trauma. Data will be collected across four time points, T=0, 14 days, 30 days and 90 days, to allow for building and validating the algorithms for both diagnosis and prognosis claims.
Control populations, healthy and trauma only (no head trauma) will be included for assay development. Data will be collected for these groups at T=0 and 14 days (trauma control only).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Target Condition
Subjects presenting to the Emergency Department (ED) or Urgent Care (UC) with a blunt head trauma
Cognitive Assessment
Self administered cognitive battery
Patient Reported Neurological Outcome Assessments
Standard neurocognitive and neuropsychological tests
Blood Draw
Specimen collection of whole blood, serum, RNA
Trauma Control
Subjects presenting to the ED or UC requiring an Xray but do not have a head trauma
Cognitive Assessment
Self administered cognitive battery
Patient Reported Neurological Outcome Assessments
Standard neurocognitive and neuropsychological tests
Blood Draw
Specimen collection of whole blood, serum, RNA
Healthy Control
Subjects that are healthy and not taking any prescription medications
Cognitive Assessment
Self administered cognitive battery
Blood Draw
Specimen collection of whole blood, serum, RNA
Interventions
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Cognitive Assessment
Self administered cognitive battery
Patient Reported Neurological Outcome Assessments
Standard neurocognitive and neuropsychological tests
Blood Draw
Specimen collection of whole blood, serum, RNA
Eligibility Criteria
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Inclusion Criteria
2. Ability to provide a blood sample; within 96 hours of injury
3. Ability to provide informed consent. Consent may be obtained with assistance of a legally authorized representative (LAR)
4. Must present to the Emergency Department (ED) or Urgent Care (UC) with a blunt head trauma
Exclusion Criteria
2. Need for general anesthesia at the time of presentation in the ED
3. Diagnosed dementia requiring assistance for daily living
4. Any head trauma requiring medical attention from a physician within the last 6 months
5. Received chemotherapy or radiation within the last year
6. History of stroke with disabling outcomes, brain tumor, epilepsy or intracranial surgery/hemorrhage
7. Psychiatric hospitalization in the last 90 days
8. Blood transfusion within the prior 4 weeks
9. Non-working telephone number
10. Current participant in an interventional clinical trial
11. Cannot perform study tasks on an iPad (e.g. not wearing corrective lenses necessary to read, inability to use both hands)
12. Subject considered unsuitable for participation in this clinical trial by PI, treating clinician or research study staff
Control Subjects
Inclusion:
1. Age \>=18 years
2. Ability to provide a blood sample; (For Trauma Controls (TC's) within 96 hours of injury)
3. Ability to provide informed consent. (For TC's consent may be obtained with assistance of a legally authorized representative (LAR)
4. Presents to the Emergency Department or Urgent Care with at least one injury requiring an X-Ray (TC's only)
5. Healthy and not taking prescription medications (Healthy Controls (HC's) only)
Exclusion:
1. Head trauma or symptoms with head trauma at presentation
2. Head trauma requiring medical attention from a physician within the last 6 months
3. Internal organ injury (e.g. liver laceration, pulmonary contusion, spinal cord injury) that requires inpatient hospitalization
4. Need for general anesthesia at the time of presentation in the ED
5. Diagnosed dementia requiring assistance for daily living
6. Received chemotherapy or radiation within the last year
7. History of stroke with disabling outcomes, brain tumor, epilepsy or intracranial surgery/hemorrhage
8. Psychiatric hospitalization in the last 90 days
9. Blood transfusion within the prior 4 weeks
10. Non-working telephone number
11. Current participant in an interventional clinical trial
12. Cannot perform study tasks on an iPad (e.g. not wearing corrective lenses necessary to read, inability to use both hands)
13. Subject considered unsuitable for participation in this clinical trial by PI, treating clinician or research study staff
18 Years
ALL
Yes
Sponsors
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BRAINBox Solutions Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Frank Peacock, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
Detroit Receiving
Detroit, Michigan, United States
Harper University Hospital
Detroit, Michigan, United States
Sinai Grace Hospital
Detroit, Michigan, United States
University of Rochester Medical Center
Rochester, New York, United States
Stony Brook Medicine
Stony Brook, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
John Peter Smith (JPS) Health Network
Fort Worth, Texas, United States
Baylor College of Medicine/Ben Taub
Houston, Texas, United States
Baylor College of Medicine/St. Luke's Medical Center
Houston, Texas, United States
Carilion Clinic
Roanoke, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Lucas Lemar
Role: primary
Justin Sabol
Role: primary
Justin Sabol
Role: primary
Justin Sabol
Role: primary
Kian Merchant-Borna, MPH, MBA
Role: primary
Maria Taylor
Role: primary
Hannah Zamore
Role: primary
Maximillian Masuda
Role: primary
Kelly Keene
Role: primary
Kelly Keene
Role: primary
Daniella Rodriguez
Role: primary
Other Identifiers
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CLIN01001
Identifier Type: -
Identifier Source: org_study_id
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