Using Machine Learning and Biomarkers for Early Detection of Delayed Cerebral Ischemia
CIDAIBASSAH
Machine Learning and Biomarkers for Early Detection of Delayed Cerebral Ischemia
1 other identifier
observational
1,500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2024
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2023
CompletedFirst Posted
Study publicly available on registry
October 6, 2023
CompletedStudy Start
First participant enrolled
January 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2033
January 12, 2026
January 1, 2026
10 years
September 26, 2023
January 8, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Early warning system
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.
2023-2033
Autoregulation
xyz
2023-2033
Study Arms (2)
Delayed cerebral ischemia
Definition by Vergouwen et al. Verified by computed tomography
Non-delayed cerebral ischemia
No signs of cerebral ischemia clinically or by computed tomography.
Interventions
No intervention
Eligibility Criteria
Adult people with aneurysmal subarachnoid hemorrhage
You may qualify if:
- Patients over the age of 18 with aneurysmal subarachnoid hemorrhage admitted to intensive care units at Sahlgrenska University hospital.
You may not qualify if:
- Unable to consent,
- Cardiac arrythmia,
- Previous brain damage
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sahlgrenska University Hospital
Gothenburg, 41345, Sweden
Biospecimen
Blood Cerebrospinal fluid
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
September 26, 2023
First Posted
October 6, 2023
Study Start
January 1, 2024
Primary Completion (Estimated)
December 31, 2033
Study Completion (Estimated)
December 31, 2033
Last Updated
January 12, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share