Development and Validation of a Prognostic Model for Neurocritical Patients Using Multimodal Brain Monitoring

NCT07115459 | Not Yet Recruiting

• 1 other identifier: 2024070747-2
• Study Type: observational
• Target: 167
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Brain Injury Coma; Neurocritical Care; Cerebral Infarction; Intracranial Hemorrhages; Subarachnoid Hemorrhage; Severe Traumatic Brain Injury

Keywords

Multimodal Brain Monitoring; Prognostic Model

Outcome Measures

Primary Outcomes (1)

• 90-day Outcome Prediction

  The primary outcome is the prediction of patient status at 90 days post-ICU admission, categorized as awake, comatose, or deceased.

  90-day

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Neurocritical patients aged 18-80 years with acute brain injury admitted to the ICU.

You may qualify if:

• Aged 18-80 years, no gender restrictions.
• Diagnosed with acute brain injury (ABI), including one of the following: large cerebral infarction, supratentorial large-volume intracerebral hemorrhage, subarachnoid hemorrhage, or severe traumatic brain injury, with imaging evidence (CT or MRI) supporting the diagnosis.
• On ICU admission, Glasgow Coma Scale (GCS) eye response = 1 (no eye opening) and motor score ≤ 5 (does not follow commands); or within 48 hours, neurological deterioration with no eye opening and motor score reduced to ≤ 5 (total GCS score ≤ 8).
• Able to undergo continuous multimodal monitoring, with an expected ICU stay of ≥72 hours.
• Informed consent signed by the family or legal representative.

You may not qualify if:

• Confirmed brain death on admission or imaging showing irreversible brain herniation.
• Severe trauma unrelated to brain injury (e.g., multiple fractures, spinal cord injuries, or visceral rupture) that may interfere with brain function monitoring or outcome assessment.
• Pre-existing severe neurological disorders such as epilepsy, severe encephalopathy, or chronic intracranial conditions (e.g., brain tumors or hydrocephalus).
• Inability to perform multimodal monitoring due to technical issues (e.g., equipment failure or sensor installation problems).
• Predicted survival time \<24 hours after admission, or family members choose to withdraw treatment.
• Refusal to participate in the study by the patient or their legal representative.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead
• Changsha Fourth Hospital: collaborator

MeSH Terms

Conditions

Cerebral Infarction; Intracranial Hemorrhages; Subarachnoid Hemorrhage; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Hemorrhage; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: August 11, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share