HEAD Injury Serum Markers and Multi-modalities for Assessing Response to Trauma
HeadSMART II
1 other identifier
observational
2,000
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2020
Shorter than P25 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2020
CompletedFirst Posted
Study publicly available on registry
June 9, 2020
CompletedStudy Start
First participant enrolled
December 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedAugust 4, 2021
May 1, 2021
11 months
June 5, 2020
August 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Correlation of mild traumatic brain injury diagnosis using the BRAINBox TBI Test compared to the Expert Clinical Diagnosis
Sensitivity and specificity of the diagnosis as compared to a clinical diagnosis by an expert committee
30 days
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.
Sensitivity and specificity of the risk for chronic symptoms as compared to the post-concussion symptoms at predefined time points
up to 90 days
Study Arms (3)
Target Condition
Subjects presenting to the Emergency Department (ED) or Urgent Care (UC) with a blunt head trauma
Trauma Control
Subjects presenting to the ED or UC requiring an Xray but do not have a head trauma
Healthy Control
Subjects that are healthy and not taking any prescription medications
Interventions
Self administered cognitive battery
Standard neurocognitive and neuropsychological tests
Specimen collection of whole blood, serum, RNA
Eligibility Criteria
Subjects presenting to the Emergency Department or Urgent Care with a blunt head trauma.
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
- Age \>=18 years
- Ability to provide a blood sample; (For Trauma Controls (TC's) within 96 hours of injury)
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Detroit Receiving
Detroit, Michigan, 48201, United States
Harper University Hospital
Detroit, Michigan, 48201, United States
Sinai Grace Hospital
Detroit, Michigan, 48235, United States
University of Rochester Medical Center
Rochester, New York, 14620, United States
Stony Brook Medicine
Stony Brook, New York, 11794, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
John Peter Smith (JPS) Health Network
Fort Worth, Texas, 76104, United States
Baylor College of Medicine/Ben Taub
Houston, Texas, 77030, United States
Baylor College of Medicine/St. Luke's Medical Center
Houston, Texas, 77030, United States
Carilion Clinic
Roanoke, Virginia, 24014, United States
Biospecimen
Specimen Samples for the analysis of biomarkers include: 1. Serum 2. RNA 3. Whole blood
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frank Peacock, MD
Baylor College of Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2020
First Posted
June 9, 2020
Study Start
December 31, 2020
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
August 4, 2021
Record last verified: 2021-05