Clinical trial NCT06069973: Using Machine Learning and Biomarkers for Early Detection of Delayed Cerebral Ischemia
Official title: Machine Learning and Biomarkers for Early Detection of Delayed Cerebral Ischemia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ischemic Stroke
Hemorrhagic Stroke
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult people with aneurysmal subarachnoid hemorrhage

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Early warning system
timeFrame: 2023-2033
measure: Autoregulation
timeFrame: 2023-2033
Secondary outcomes:
Other outcomes:
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