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临床试验/NCT03287557
NCT03287557已完成不适用

Dysregulated CNS Inflammation After Acute Brain Injury

University of Kentucky1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2018年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
1
主要终点
Severe TBI - Measure of temporal profile of inflammatory proteins in CSF

研究概览

简要总结

By doing this study, the investigator hopes to learn how the levels of important proteins involved in inflammation change over time in patients with acute brain injury. The total amount of time participants will be asked to volunteer for this study is approximately two hours over a five day period.

详细描述

This pilot project is a prospective, observational study in 20 patients who are admitted to University of Kentucky (UK) Chandler Medical Center with a diagnosis of severe, non-penetrating traumatic brain injury (TBI) or aneurysmal subarachnoid hemorrhage (aSAH).

All adult participants with a primary diagnosis of severe, non-penetrating TBI or aSAH who are admitted to the neuroscience or trauma intensive care units will be screened for potential inclusion into this study. Once a potential participant is identified, the legally-authorized representative will be approached for study consent and HIPAA authorization. If the participant regains consent capacity before the end of the cerebrospinal fluid (CSF) collection period, assent will be obtained from the research participant.

In this research study, up to 5 small samples of CSF, will be carefully removed from the device, already in place, that drains excess CSF from the participant's head. The samples will be less than 1 teaspoon (< 5 mL) each. These samples will be frozen and stored until samples from approximately 20 participants have been obtained.

These samples will then be prepared and sent to a research laboratory to analyze the proteins in the samples collected from each research participant.

Because the results of this study will not affect the treatment participants receive in or outside of the hospital, the investigator will not share the results of this study with the participant, their doctor or their family member(s).

研究设计

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

入排标准

年龄范围
18 Years 至 101 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • severe, non-penetrating TBI or aSAH
  • must have a ventriculostomy (EVD) placed by the UK Neurosurgery service within 12 hours of primary traumatic episode

排除标准

  • non-survivable brain injury or other organ system injury
  • life expectancy is five days or less
  • penetrating TBI
  • status epilepticus upon arrival to the hospital
  • severe ischemic heart disease or congestive heart failure, myocardial infarction, or spinal cord injury
  • Takotsubo cardiomyopathy secondary to the SAH
  • active cancer or have been treated for cancer within the previous 6 months

结局指标

主要结局

Severe TBI - Measure of temporal profile of inflammatory proteins in CSF

时间窗: For 24 months from start of the study

CSF collection

次要结局

  • aSAH - Measure of temporal profile of inflammatory proteins in CSF(For 24 months from start of the study)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Linda Van Eldik

Sponsor Investigator

University of Kentucky

研究点 (1)

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