Transforming Research and Clinical Knowledge in Traumatic Brain Injury Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 650
- 试验地点
- 4
- 主要终点
- Glasgow Outcome Scale Extended (GOSE)
研究概览
简要总结
The global aim of this proposal is to test and refine Common Data Elements (CDEs), neuroimaging standards, and best practices for genetics and proteomics in Traumatic Brain Injury (TBI) studies. Testing and validating of TBI-CDEs will be performed in a multi-center prospective observational study with 3 TBI Centers (San Francisco General Hospital (SFGH), University of Pittsburgh Medical Center (UPMC), University Medical Center Brackenridge (UMCB)) and a TBI Rehabilitation Center (Mount Sinai Rehabilitation Center (MSMC)). The investigators will create and expand existing data repositories for patient demographics, neuroimaging, plasma biomarkers, genetics, and multivariate outcomes thereby providing researchers and clinicians with the infrastructure to establish multidisciplinary, multicenter research networks and improve clinical research in the TBI field.
详细描述
The Investigators aim for a 10-month data collection period for TBI patients across the spectrum from concussion to coma with a limited 3-month follow up and extensive 6-, 12-, and 24-month follow ups. Patient enrollment will occur in three high-volume TBI Centers (SFGH, UPMC, UMCB) and a TBI Rehabilitation Center (MSMC). These Centers have a long track record of multi-center TBI research experience as well as existing infrastructure for rapid start-up and sustained enrollment. All patients admitted acutely with a history of external force injury to the head with a head CT performed in the emergency department are eligible for enrollment. Head CTs are performed according to the American College of Emergency Physicians (ACEP) and the Centers for Disease Control and Prevention (CDC) Guidelines for neuroimaging and decision making in TBI. These Guidelines are already in place at the participating Centers and are used to determine which patients will receive a non-contrast head CT scan as part of their initial evaluation. Patients will not be excluded based on age, race, gender, ethnicity, substance abuse, or prior psychiatric history to provide a population-based sample of of TBI subjects across the injury spectrum from concussion to coma.
Study Components (Ref: NIH-NINDS TBI Common Data Elements):
- Clinical Care and Demographic Data Collection. Variables include: date and time of injury, mechanism of injury, acute laboratory values and vital signs, neurological evaluations, surgical interventions, hospital course, morbidity and mortality during acute care.
- Blood Draw for Proteomic and Genetic Marker Analyses. Blood samples will be drawn within 24 hours of injury. Plasma will be spun and separated from whole blood. Both plasma and whole blood samples will be banked centrally under -80 degrees Celsius at the University of California, San Francisco (UCSF) DNA Bank.
- 3-Tesla (3T) Magnetic Resonance Imaging. A 3T Research MRI will be completed on a subset of patients able to return 1-2 weeks post-injury.
- 3-Month Follow Up. The Glasgow Outcome Scale - Extended (GOS-E) and neurological symptoms inventory will be administered to patients over the phone 3 months post-injury.
- 6-, 12-, and 24-Month Neurocognitive Assessment. Standardized measures from all designated CORE domains for outcome after TBI by TBI-CDEs, which include: global recovery, functional outcome, psychological impairment, post-traumatic stress disorder (PTSD), and quality of life, will be administered to the participant.
The investigators anticipate that this project has the potential to substantially advance and revolutionize clinical research in TBI. Repositories for neuroimaging, proteomic, and genetic biomarkers will facilitate the evolving field of these emerging technologies in TBI.
Recent Publications:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presentation to Emergency Department < 24 hours post-injury
- •Head CT scan for Traumatic Brain Injury (TBI) as part of regular care.
- •English Speaking
排除标准
- •Presentation to Emergency Department > 24 hours post-injury
- •Custody or Incarceration
- •5150 Psychiatric Hold
- •Component-Specific Exclusion Criteria:
- •MRI: Pregnant or may be pregnant; younger than 8 years old; those who have cardiac pacemakers, neural pacemakers, surgical clips in the brain or blood vessels, surgically implanted metal plates, screws or pins, cochlear implants, intrauterine devices (IUDs), or metal objects in their body, especially in the eye. Persons with a history of claustrophobia are excluded from this procedure.
结局指标
主要结局
Glasgow Outcome Scale Extended (GOSE)
时间窗: 6 Months Post-Injury
The GOSE provides and overall measure of disability based on information on cognition, independence, employability, and social/community participation collected via structured interview. Individuals are described by one of the eight outcome categories: Dead (1); Vegetative State (2); Lower Severe Disability (3); Upper Severe Disability (4); Lower Moderate Disability (5); Upper Moderate Disability (6); Lower Good Recovery (7) and Upper Good Recovery (8). Good Recovery is defined as a score of 7-8, Moderate Disability is defined by a score of 5-6 and Severe Disability is defined by a score of 3-4.
次要结局
未报告次要终点