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临床试验/NCT04578197
NCT04578197Unknown不适用

NeuroCOVID - A Study of Activation and Inhibition of the Immune and Coagulation Systems, the Presence of Biochemical (Blood / CSF) and Structural Brain Changes and Their Association With Long-term Cognitive Dysfunction in Intensive Care-requiring Covid-19 Patients

Karolinska University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年8月18日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
The association between changes in blood biomarkers for neurodegeneration and the presence of neuroradiologically verified brain injury and neurocognitive disorder

研究概览

简要总结

Critically ill patients requiring intensive care suffer to a large extent from cognitive deficits involving higher brain functions that primarily affect memory, learning and the ability to concentrate. While the background to this effect is not fully understood, there are growing evidence to support mechanisms related to neuro inflammation and changes in blood flow with concomitant ischemic brain damage. Patients with covid-19 often suffer from severe inflammatory activity with an increased risk of coagulation abnormalities and brain damage. Covid-19 patients requiring intensive care develope more severe impairment of neurological and cognitive function than critically ill intensive care patients who have not covid-19. This project therefore aims to map the link between inflammation, immunology and coagulation systems as well as biochemical and structural changes in the brain with cognitive effects in patients in intensive care for covid-19.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Age ≥18 years
  • Need for Intensive care
  • Positive PCR test for SARS-CoV-2

排除标准

  • 未提供

结局指标

主要结局

The association between changes in blood biomarkers for neurodegeneration and the presence of neuroradiologically verified brain injury and neurocognitive disorder

时间窗: Up to 12 months

The association between changes in blood biomarkers for inflammation and the presence of neuroradiologically verified brain injury and neurocognitive disorder

时间窗: Up to 12 months

The association between changes in blood biomarkers for nerve cell damage and the presence of neuroradiologically verified brain injury and neurocognitive disorder

时间窗: Up to 12 months

次要结局

  • Blood biomarker changes of neurological impact(Up to 3 months)
  • Clinical course - Pulmonary gas exchange(Up to 3 months)
  • Clinical course - Lung function recording(Up to 3 months)
  • The association between changes in coagulation factors and the presence of neuroradiologically verified brain injury and / or neurocognitive disorder(Up to 12 months)
  • The association between changes in coagulation ability (ROTEM analysis - rotational thromboelastometry) and the presence of neuroradiologically verified brain injury and / or neurocognitive disorder(Up to 12 months)
  • The association between changes in inflammatory biomarkers and the presence of neuroradiologically verified brain injury and / or neurocognitive disorder(Up to 12 month)
  • Blood biomarker changes of inflammation impact(Up to 3 months)
  • Neuroradiological changes(Up to 3 months)
  • Patient characteristics(Up to 3 months)

研究者

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lars I Eriksson

Professor

Karolinska University Hospital

研究点 (1)

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