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临床试验/NCT04565366
NCT04565366Enrolling By Invitation不适用

Early Critical Care Decisions and Outcomes After SCI: TRACK-SCI

University of California, San Francisco5 个研究点 分布在 1 个国家目标入组 726 人开始时间: 2015年5月14日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
726
试验地点
5
主要终点
Gene expression level in number of messenger RiboNucleic Acid (mRNA) transcripts for all genes expressed in white blood cells

研究概览

简要总结

The overall goal of Transforming Research and Clinical Knowledge in Spinal Cord Injury (TRACK-SCI) study is to determine the relationships among the clinical, neuroimaging, cognitive, genetic and proteomic biomarker characteristics of acute traumatic spinal cord injury (SCI). TRACK-SCI seeks to combine high quality care variables with high density physiology data collection to better understand diagnose, characterize, and track the temporal profile of recovery for SCI patients. The Investigators are enrolling patients within 24 hours of injury who present to a TRACK-SCI site with a spinal cord injury that meets eligibility criteria.

详细描述

Spinal cord injury (SCI) is a major cause of morbidity worldwide with debilitating impacts on quality of life and the healthcare system. To date, a data-dense research registry specific to SCI remains to be constructed. To this end, the study will collect SCI data across five primary domains: 1) demographics and baseline history, 2) clinical course variables from the emergency department (ED) to the intensive care unit (ICU), 3) standard of care neuroimaging (CT and MRI) and intraoperative neuromonitoring, 4) blood and cerebrospinal fluid (CSF) samples for proteomic and genetic biomarkers, and 5) outcome measures of functional disability, mental health and quality of life at 3, 6, and 12 months. The investigators seek to correlate these high-density physiology data with baseline risk factors, imaging parameters, and biomarkers for a comprehensive approach to SCI diagnosis during acute care as well as prognosis across subacute and chronic phases of recovery -- in order to truly step toward the advancement of research and clinical knowledge in SCI.

The main objective is to provide a comprehensive prospective analysis of multiple variables in acute SCI that impact long-term outcomes. This is intended to provide a rich resource for asking key questions related to the optimization of treatment, and the planning and execution of pivotal clinical trials in SCI.

Core Hypotheses:

  1. Multiple critical care variables will be predictive of both sensorimotor and autonomic outcomes, and susceptibility to infections at discharge and 6 and 12 mos after injury.
  2. Quantitative MRI indices of cord damage, and biomarkers of acute immune responses to injury will predict neurological outcomes at discharge and at 6 and 12 mos.
  3. The multivariate analysis of the constellation of acute variables and long-term outcome measures will yield new derived predictors of outcome that will facilitate stratification for clinical trials.

Specific Aims:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For SCI group: individuals at least 18 years of age recently diagnosed with acute, traumatic spinal cord injury
  • For Trauma Control group: individuals at least 18 years of age recently diagnosed with acute, traumatic injury that is not spinal cord injury
  • For Healthy Control group: generally healthy individuals at least 18 years of age not recently diagnosed with acute, traumatic injury (including SCI)

排除标准

  • Individuals who are pregnant
  • Individuals who are in-custody/prisoners
  • Individuals who are under psychiatric hold
  • For non-SCI individuals, they must not have had a spinal cord injury in the past
  • For non-SCI individuals, they must not have a history of previous central nervous system injury (i.e. stroke, spinal cord injury, traumatic brain injury, seizures, etc.)

结局指标

主要结局

Gene expression level in number of messenger RiboNucleic Acid (mRNA) transcripts for all genes expressed in white blood cells

时间窗: Baseline (healthy control group), or as close as possible to time of injury (SCI and trauma control group)

Obtained from a 4.0mL blood draw

International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) (SCI Only)

时间窗: From admission to 12 months post-injury

American Spinal Injury Association standard assessment for documentation of the level and severity of a spinal cord injury (SCI). The ISNCSCI yields a grade from A to D, wherein A indicates greater severity.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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