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临床试验/NCT04475263
NCT04475263Unknown不适用

Cognitive, Behavioural and Blood Biomarker Assessment After Carbon Monoxide (CO) Exposure

St George's, University of London0 个研究点目标入组 50 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
Blood biomarker level of neurofilament light in participants with proven CO exposure.

研究概览

简要总结

Carbon monoxide (CO) is reported to cause around 30 deaths, 200 admissions and 4000 presentations to Emergency Departments each year in the UK. In the longer term, CO poisoning is recognised to cause persistent neurological problems (including impairments of thinking and behavioural changes), which can develop days to weeks after the initial exposure. However, the incidence of these long-term sequelae is unknown. In addition, there is evidence of long-lasting inflammatory changes in the brain and on-going brain cell injury, although how long this persists is also unknown.

Initial assessments of CO exposure can be unreliable if blood tests are not carried out within a relatively short period after the exposure and other biomarkers (such as imaging) are insensitive to detecting previous CO exposure. Certain proteins that are found in brain cells can be detected in the blood of individuals following brain injury and brain cell death. These proteins have been found to be raised in the acute period after minor head injury, persistently raised in patients with a traumatic brain injury and evidence of on going neurodegeneration (i.e. on going brain cell death) and in patients with various types of dementia.

The investigators will assess the presence of these proteins in the blood of 50 participants with proven CO exposure in the sub-acute to chronic timescale (2 weeks to 2 years). This has not been done before and will allow assessment of the presence of on going brain injury in these participants. The investigators will also assess cognitive (e.g. memory, attention and speed of thinking) and behavioural impairments in these participants to help characterise the common impairments suffered following CO exposure and relate these to evidence of persistent brain injury and severity of CO exposure.

研究设计

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

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

  • Individuals identified as having confirmed exposure to CO between 2 weeks to 2 years at time of assessment. CO exposure determined by either;
  • documented COHb levels above 1.6% in non-smokers and above 6.3% in smokers.
  • or, individuals with evidence of being exposed to raised levels of CO and symptoms

排除标准

  • age <18 years
  • actual or suspected smoke inhalation
  • significant neurological or psychiatric illness prior to CO exposure
  • inability to provide consent

结局指标

主要结局

Blood biomarker level of neurofilament light in participants with proven CO exposure.

时间窗: 18 months

Plasma levels of neurofilament light will be measured

次要结局

  • Behavioural questionnaire: post-traumatic stress symptoms (Impact of Events Scale)(18 months)
  • Behavioural questionnaire: Attentional behaviour (Rating Scale of Attentional Behaviour)(18 months)
  • Behavioural questionnaire: fatigue (Visual Analogue Scale of Fatigue)(18 months)
  • Behavioural questionnaire: Quality of life (The Short Form (36) Health Survey)(18 months)
  • Behavioural questionnaire: return to work/social activities (Work and Social Adjustment Scale)(18 months)
  • Blood biomarker level of tau in participants with proven CO exposure.(18 months)
  • Blood biomarker level of glial fibrillary acidic protein in participants with proven CO exposure.(18 months)
  • Behavioural questionnaire: depression (Patient Health Questionnaire - part 9)(18 months)
  • Behavioural questionnaire: anxiety (Generalised Anxiety Disorder Questionnaire - GAD7)(18 months)
  • Cognitive assessment(18 months)

研究者

申办方类型
Other
责任方
Sponsor

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