Evaluation, Pathogenesis, and Outcome of Subjects With or Suspected Traumatic Brain Injury
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|ClinicalTrials.gov Identifier: NCT01132937|
Recruitment Status : Recruiting
First Posted : May 28, 2010
Last Update Posted : July 2, 2019
|First Submitted Date||May 27, 2010|
|First Posted Date||May 28, 2010|
|Last Update Posted Date||July 2, 2019|
|Actual Study Start Date||October 7, 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||Evidence of injury on MRI of the brain vasculature. Qualitative observations and quantitative measures will be reported and described in relation to history, baseline clinical variables, cognitive impairment, cognitive decline and TBI outcome s...|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT01132937 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures
||Cognitive impairment or decline; success/failure rate for acute MRI in relationship to attempted and those able to undergo CT; imaging findings on CT in comparison to that of MRI; Neurocognitive testing and TBI Outcome Scales.|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title||Evaluation, Pathogenesis, and Outcome of Subjects With or Suspected Traumatic Brain Injury|
|Official Title||Evaluation, Pathogenesis, and Outcome of Subjects With or Suspected Traumatic Brain Injury|
- Traumatic brain injury may have a range of effects, from severe and permanent disability to more subtle functional and cognitive deficits that often go undetected during initial treatment. To improve treatments and therapies and to provide a uniform quality of care, researchers are interested in developing more standardized criteria for diagnosing and classifying different types of traumatic brain injury. By identifying imaging and other indicators immediately after the injury and during the initial treatment phrase, researchers hope to better understand the nature and effects of acute traumatic brain injury.
- Individuals at least 18 years of age who have been admitted to a hospital with a diagnosed or suspected traumatic brain injury within the past 48 hours.
To generate natural history data for cohort-based comparisons to serve as the basis for future hypothesis-driven protocols and to contribute to the clinical and physiological understanding of traumatic brain injury (TBI) through the description of manifestations of the injury and the relationship among radiological, hematological, clinical variables and standard functional outcome measures.
One thousand male and female adult subjects with history of recent head injury with or suspected non-penetrating acute TBI, will be enrolled. Subjects having varying degrees of TBI severity will be recruited from the collaborative programs between NIH and non-NIH hospitals. We anticipate approximately 80% of subjects will be classified as mild TBI, concussion, or no injury, with approximately two thirds of those subjects enrolled being discharged directly from the emergency department.
This is a prospective cohort study of subjects with known and suspected non-penetrating acute traumatic brain injury. Subjects presenting to the emergency department or trauma service at participating hospitals with a history of recent head injury will be studied during the course of their hospital stay and after discharge using radiological, hematological, clinical and functional outcome measures. Subjects will be stratified according to findings into cohorts for comparison. The design is intentionally broad in scope to allow acquisition of initial data for the development of future hypothesis-driven protocols. Research performed under this protocol will not interfere with standard of care and subjects will not be treated with experimental therapies as part of the research study. Data collected under this research study may be shared without personal identifiers with other researchers if subjects approve this option on the informed consent.
A variety of outcome measures will be used including diagnosis, evidence of injury on magnetic resonance imaging (MRI) and positron emission tomography (PET), functional impairment, and quality of life (QOL) assessments. The initial research questions will focus on a positive diagnosis of brain injury and monitoring the natural history. Statistical analysis plans will be developed as specific research questions and hypotheses are generated.
|Study Design||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition||Traumatic Brain Injury|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Estimated Enrollment
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
Suspected TBI Subjects
Suspected TBI subjects must meet the following inclusion criteria:
Healthy volunteers must meet the following inclusion criteria:
Suspected TBI Subjects
Suspected TBI subjects are not eligible for participation in this research study if any of the following conditions exist:
Healthy volunteers are not eligible for participation in this research study if any of the following conditions exist:
Currently phase 1 of enrollment for healthy volunteers in the A Beta PET pilot is complete. At this time enrollment of healthy volunteers is on hold until analysis complete. Enrollment of A Beta PET pilot TBI subjects and healthy matches may resume under Phase-2 if analysis of initial data suggests update
|Ages||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||100122
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )|
|Study Sponsor||National Institute of Neurological Disorders and Stroke (NINDS)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||December 6, 2018|