HEAD Injury Serum Markers and Multi-modalities for Assessing Response to Trauma

Status unconfirmed

Conditions studied: Mild Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT04423198

Run by

BRAINBox Solutions Inc

People needed

2000

Starts

2020-12-31

Expected to finish

2021-12-01

Last updated by the study team

2021-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)
• Detroit Receiving — Detroit, Michigan, United States (enrolling)
• Harper University Hospital — Detroit, Michigan, United States (enrolling)
• Sinai Grace Hospital — Detroit, Michigan, United States (enrolling)
• University of Rochester Medical Center — Rochester, New York, United States (enrolling)
• Stony Brook Medicine — Stony Brook, New York, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• John Peter Smith (JPS) Health Network — Fort Worth, Texas, United States (enrolling)
• Baylor College of Medicine/Ben Taub — Houston, Texas, United States (enrolling)
• Baylor College of Medicine/St. Luke's Medical Center — Houston, Texas, United States (enrolling)
• Carilion Clinic — Roanoke, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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