Ignite Creation Date:
2025-12-24 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:32 PM
Study NCT ID:
NCT07115459
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-11
First Post:
2025-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development and Validation of a Prognostic Model for Neurocritical Patients Using Multimodal Brain Monitoring
Sponsor:
Xiangya Hospital of Central South University
Organization:
Study Overview
Official Title:
Protocol for Developing and Validating a Multimodal Brain Monitoring-Based Prognostic Model for Neurocritical Patients: A Prospective, Observational, Multicenter Cohort Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to develop and validate a prognostic model for neurocritical patients using multimodal brain monitoring data. By combining data from various monitoring techniques such as EEG, TCD, and NIRS, this model will help predict 90-day outcomes (awake, comatose, or deceased) and support personalized treatment decisions. The study is observational and involves no experimental interventions.
Detailed Description:
This study is a prospective, observational, multicenter cohort study conducted in China. It focuses on neurocritical patients with acute brain injury, including large cerebral infarction, intracranial hemorrhage, subarachnoid hemorrhage, or severe traumatic brain injury. The study will collect multimodal data from EEG, TCD, and NIRS monitoring within 1-3 days of ICU admission. Machine learning algorithms will be used to develop a model predicting 90-day outcomes, categorized as awake, comatose, or deceased. The study population includes patients aged 18-80 years. Exclusion criteria include pre-existing severe neurological disorders, incomplete monitoring data, or withdrawal during the study period.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: