Status:
UNKNOWN
HEAD Injury Serum Markers and Multi-modalities for Assessing Response to Trauma
Lead Sponsor:
BRAINBox Solutions Inc
Conditions:
Mild Traumatic Brain Injury
Eligibility:
All Genders
18+ years
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 p...
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 su...
Eligibility Criteria
Inclusion
- Target Condition Subjects
- Age \>=18 years
- Ability to provide a blood sample; within 96 hours of injury
- Ability to provide informed consent. Consent may be obtained with assistance of a legally authorized representative (LAR)
- Must present to the Emergency Department (ED) or Urgent Care (UC) with a blunt head trauma
Exclusion
- Glasgow Coma Scale (GCS) score \< 13, as presented in ED at time of screening
- Need for general anesthesia at the time of presentation in the ED
- Diagnosed dementia requiring assistance for daily living
- Any head trauma requiring medical attention from a physician within the last 6 months
- Received chemotherapy or radiation within the last year
- History of stroke with disabling outcomes, brain tumor, epilepsy or intracranial surgery/hemorrhage
- Psychiatric hospitalization in the last 90 days
- Blood transfusion within the prior 4 weeks
- Non-working telephone number
- Current participant in an interventional clinical trial
- Cannot perform study tasks on an iPad (e.g. not wearing corrective lenses necessary to read, inability to use both hands)
- Subject considered unsuitable for participation in this clinical trial by PI, treating clinician or research study staff
- Control Subjects
- Inclusion:
- Age \>=18 years
- Ability to provide a blood sample; (For Trauma Controls (TC's) within 96 hours of injury)
- Ability to provide informed consent. (For TC's consent may be obtained with assistance of a legally authorized representative (LAR)
- Presents to the Emergency Department or Urgent Care with at least one injury requiring an X-Ray (TC's only)
- Healthy and not taking prescription medications (Healthy Controls (HC's) only)
- Exclusion:
- Head trauma or symptoms with head trauma at presentation
- Head trauma requiring medical attention from a physician within the last 6 months
- Internal organ injury (e.g. liver laceration, pulmonary contusion, spinal cord injury) that requires inpatient hospitalization
- Need for general anesthesia at the time of presentation in the ED
- Diagnosed dementia requiring assistance for daily living
- Received chemotherapy or radiation within the last year
- History of stroke with disabling outcomes, brain tumor, epilepsy or intracranial surgery/hemorrhage
- Psychiatric hospitalization in the last 90 days
- Blood transfusion within the prior 4 weeks
- Non-working telephone number
- Current participant in an interventional clinical trial
- Cannot perform study tasks on an iPad (e.g. not wearing corrective lenses necessary to read, inability to use both hands)
- Subject considered unsuitable for participation in this clinical trial by PI, treating clinician or research study staff
Key Trial Info
Start Date :
December 31 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT04423198
Start Date
December 31 2020
End Date
December 1 2021
Last Update
August 4 2021
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
2
Detroit Receiving
Detroit, Michigan, United States, 48201
3
Harper University Hospital
Detroit, Michigan, United States, 48201
4
Sinai Grace Hospital
Detroit, Michigan, United States, 48235