Clinical trial NCT04423198: HEAD Injury Serum Markers and Multi-modalities for Assessing Response to Trauma
Official title: HEAD Injury Serum Markers and Multi-modalities for Assessing Response to Trauma II
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mild Traumatic Brain Injury
Keywords: TBI, mTBI
Lead sponsor: BRAINBox Solutions Inc
Sponsor class: INDUSTRY
First posted: 2020-06-09
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects presenting to the Emergency Department or Urgent Care with a blunt head trauma.

Brief summary: The goal of HeadSMART II (HEAD injury Serum markers and Multi-modalities for Assessing Response to Trauma II) is to develop an In-Vitro Diagnostic, the BRAINBox TBI test, to aid in the diagnosis and prognosis of patients with mild traumatic brain injury, by incorporating blood biomarkers, clinical assessments, and tools to measure associated neurocognitive impairments.

Detailed description: This study proposes to collect data using a multi-modality approach including blood biomarkers, clinical assessments, neurocognitive performance, and neuropsychological characteristics, to identify subjects with a mild Traumatic Brain Injury (TBI) and their likelihood of chronic symptoms.

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).

Eligibility criteria: Target Condition Subjects

Inclusion Criteria:

1. Age \>=18 years
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:

1. Glasgow Coma Scale (GCS) score \< 13, as presented in ED at time of screening
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

Primary outcomes:
measure: Correlation of mild traumatic brain injury diagnosis using the BRAINBox TBI Test compared to the Expert Clinical Diagnosis
timeFrame: 30 days
measure: Determine the risk stratification of having symptoms at 14, 30 and 90 days, for subjects with mild traumatic brain injury using the BRAINBox TBI Test results.
timeFrame: up to 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Detroit
country: United States
facility: Detroit Receiving
state: Michigan
city: Detroit
country: United States
facility: Harper University Hospital
state: Michigan
city: Detroit
country: United States
facility: Sinai Grace Hospital
state: Michigan
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Medicine
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Fort Worth
country: United States
facility: John Peter Smith (JPS) Health Network
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine/Ben Taub
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine/St. Luke's Medical Center
state: Texas
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
Study officials:
affiliation: Baylor College of Medicine
name: Frank Peacock, MD
role: PRINCIPAL_INVESTIGATOR
References: