NCT01786447
Terminated
Not Applicable
Biomarkers of Brain Injury: Magnitude and Outcome of Mild and Moderate TBI
ConditionsBrain Injuries, Traumatic
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Brain Injuries, Traumatic
- Sponsor
- Banyan Biomarkers, Inc
- Enrollment
- 111
- Locations
- 1
- Primary Endpoint
- Assessment of biomarkers to identify patients with TBI from orthopedic controls
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this study is to determine if specific brain injury biomarkers have utility as blood-based traumatic brain injury (TBI) diagnostic and monitoring tools. This will be accomplished by examining the relationships between potential serum-based TBI biomarkers and clinical measures of injury severity, occurrence of complications, and outcome, in subjects with mild or moderate TBI as well as in orthopedic control subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 years or older
- •CT scan as part of clinical evaluation
- •experienced some level of altered mental state at time of injury
- •determination of study eligibility within 4 hours of injury
Exclusion Criteria
- •Pregnant females
- •Anemia or significant blood loss (hemoglobin \< 12 mg/dL and/or hematocrit \< 35%, and/or clinical state requiring resuscitation with more than 6L of colloid or crystalloid fluid)
- •no clear history of trauma as primary event
- •previous history of stroke, or head injury requiring hospitalization
- •dementia or psychotic illness or neurological condition which may affect outcome
- •unable to speak or understand English
- •Orthopedic Control Group
- •Inclusion Criteria:
- •18 years or older
- •Isolated extracranial orthopedic injury, including fractures
Outcomes
Primary Outcomes
Assessment of biomarkers to identify patients with TBI from orthopedic controls
Time Frame: 4 hours
Secondary Outcomes
- Assessment of biomarkers to identify patients with brain lesions on CT scan(4 hours)
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Biomarkers of Mild and Moderate Traumatic Brain InjuryBrain Injuries, TraumaticNCT01295346Banyan Biomarkers, Inc290
Completed
Not Applicable
Brain Injury Biomarkers in the General PopulationBrain Injuries, TraumaticNCT01786460Banyan Biomarkers, Inc800
Completed
Not Applicable
Definition, Quantification, and Utility of Biomarkers of Repetitive Brain Injury in Predicting Concussion and Other Long-Term Injury Risks in Patients With Atrial Fibrillation (Concussion AF)Cognitive ChangeNCT03875131Intermountain Health Care, Inc.120
Recruiting
Not Applicable
Multiomic Analysis of Traumatic Brain Injury and Hypertension Intracranial Hemorrhage Lesion TissueBrain Injury Traumatic SevereIntracranial Hemorrhage, HypertensiveNCT05778110RenJi Hospital10
Terminated
Not Applicable
Developing Therapies for Traumatic Brain InjuryTraumatic Brain InjuryNCT01420939National Institute of Nursing Research (NINR)19