Evaluation, Pathogenesis, and Outcome of Subjects With or Suspected Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title: Evaluation, Pathogenesis, and Outcome of Subjects With or Suspected Traumatic Brain Injury

Status Completed

Clinical Trial Summary

Background:

• 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.

Objectives:

• To study the MRI results of individuals who have recently had head injury and suspected traumatic brain injury.

• To study the natural evolution of traumatic brain injury for up to 3 months after head injury.

Eligibility:

• 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.

Design:

• Participants will have one 3-hour study visits: an initial visit (within 48 hours of head injury). Participants may be asked to have an optional 4-day, 30-day, 90-day, and 1-year follow-up.

• Each visit may involve blood samples, an MRI scan (approximately 30 minutes), and a series of tests to evaluate brain function.

• At the optional follow-up visit, participants may have blood samples, an MRI scan, and a general traumatic brain injury assessment.

• This study does not provide treatment and does not replace any current therapies. However, participants who are eligible for other National Institutes of Health studies may be referred to these studies by researchers.

Clinical Trial Description

Objective

To generate natural history data for cohort-based comparisons to serve as the basis for hypothesis-driven studies 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.

Study Population

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.

Design

This is a prospective 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 suspected 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 and time of initial imaging into cohorts for comparison.

The design is intentionally broad in scope to allow acquisition of data for the development of future hypothesis-driven research. 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. Data and samples collected under this protocol and other protocols that allow data sharing will be combined for secondary analysis under this protocol.

Outcome Measures

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. 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. ;

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

• NCT number: NCT01132937
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Status: Completed
• Start date: October 7, 2010