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NCT01132937 · ClinicalTrials.gov registry record
Evaluation, Pathogenesis, and Outcome of Subjects With or Suspected Traumatic Brain Injury
A clinical trial, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- 886
- Enrollment target
NCT01132937: Completed study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT01132937 is a clinical trial that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 886 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01132937 has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- 886 participants
- Enrollment target
Study 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.
Primary Outcome
Qualitative observations and quantitative measures will be reported and described in relation to history, baseline clinical variables, and TBI outcome scales
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 886 participants |
| Start Date | 2010-10-07 |
What the finished NCT01132937 record still lists
NCT01132937 is an observational study that tracks outcomes without assigning an intervention. The registered 886 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01132937 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01132937 about?
NCT01132937 is a clinical study titled "Evaluation, Pathogenesis, and Outcome of Subjects With or Suspected Traumatic Brain Injury". 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 i...
What is the current status of trial NCT01132937?
This trial is currently completed. The enrollment target is 886 participants. The study started on 2010-10-07.
Who is sponsoring clinical trial NCT01132937?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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