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临床试验/NCT06069973
NCT06069973招募中不适用

Machine Learning and Biomarkers for Early Detection of Delayed Cerebral Ischemia

Sahlgrenska University Hospital2 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,500
试验地点
2
主要终点
Autoregulation

研究概览

简要总结

The overall goal of this project is to determine if machine learning and analysis of neurospecific biomarkers can enable early detection of upcoming or ongoing cerebral ischaemia in patients suffering from subarachnoid haemorrhage with altered consciousness due to cerebral injury or sedation. Analyses of heart rate variability, electroencephalgraphy,nearinfrared spectroscopy, cerebral autoregulation, and brain injury specific biomarkers in blood and cerebrospinal fluid will be performed.

详细描述

A new and promising approach to detect ongoing cerebral ischemia might be the detection of neurospecific biomarkers in blood. A biomarker for cerebral ischaemia, similar to troponin T and troponin I for detecting cardiac ischaemia, would be precious; however, such a biomarker for cerebral ischaemia is currently lacking. (9) There are several interesting neurospecific biomarkers for this purpose, such as Glial fibrillary acidic protein (GFAP), neuron-specific enolase (NSE), total tau, S-100, and neurofilament light chains (NFL). At this point, we do not have enough knowledge about levels of neurospecific biomarkers in blood and cerebrospinal fluid during delayed cerebral ischemia after subarachnoid hemorrhage. The sampling of neurospecific biomarkers have a dual purpose, the first is to investigate if we can detect ongoing cerebral ischemia with these biomarkers, and the second purpose is to compare levels of biomarkers to outcome in mortality and morbidity determined by the Glasgow Coma Scale Extended at 1-year, 3-years and 5-years after admission.

Machine learning algorithms for predicting outcomes after delayed cerebral ischemia using a combination of clinical and imaging data have emerged. Nevertheless, prediction of delayed cerebral ischemia does not prevent it; to prevent delayed cerebral ischemia, an easily applied, cheap and reliable monitoring system that can warn physicians of the imminent risk of cerebral ischemia needs to be developed, making it possible to intervene.

The overall goal of this project is to develop methods that enable the detection of upcoming or ongoing cerebral ischaemia in patients with subarachnoid haemorrhage

Our primary aims are:

  • To develop a machine learning-based model that can identify patterns in signals obtained from HRV, NIRS, and EEG monitoring, which are consistent with upcoming cerebral ischemia and provide a warning about this to attending physicians.
  • To define the specificity and time relation of neurospecific biomarkers in blood and cerebrospinal fluid in patients with subarachnoid haemorrhage with and without delayed cerebral ischemia to evaluate if any of these biomarkers can be used as an indicator for ongoing cerebral ischemia.
  • To assess the prognostic value of changes in physiological and neurospecific biomarkers changes during the acute phase after subarachnoid hemorrhage on long-term outcome.

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 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over the age of 18 with aneurysmal subarachnoid hemorrhage admitted to intensive care units at Sahlgrenska University hospital.

排除标准

  • Unable to consent,
  • Cardiac arrythmia,
  • Previous brain damage

研究组 & 干预措施

Non-delayed cerebral ischemia

No signs of cerebral ischemia clinically or by computed tomography.

干预措施: No intervention, observational study (Other)

Delayed cerebral ischemia

Definition by Vergouwen et al. Verified by computed tomography

干预措施: No intervention, observational study (Other)

结局指标

主要结局

Autoregulation

时间窗: 2023-2033

xyz

Early warning system

时间窗: 2023-2033

To develop a machine learning-based model that can identify patterns in signals obtained from HRV, NIRS, and EEG monitoring, which are consistent with upcoming cerebral ischemia and provide a warning about this to attending physicians. To define the specificity and time relation of neurospecific biomarkers in blood and cerebrospinal fluid in patients with subarachnoid haemorrhage with and without delayed cerebral ischemia to evaluate if any of these biomarkers can be used as an indicator for ongoing cerebral ischemia. To assess the prognostic value of changes in physiological and neurospecific biomarkers changes during the acute phase after subarachnoid hemorrhage on long-term outcome.

次要结局

未报告次要终点

研究者

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

Linda Block

Dr

Sahlgrenska University Hospital

研究点 (2)

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