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Not yet recruiting NCT07115459

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

— Observational Acute Brain Injury Coma Neurocritical Care Cerebral Infarction Intracranial Hemorrhages

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Acute Brain Injury Coma, Neurocritical Care, Cerebral Infarction, Intracranial Hemorrhages. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Protocol for Developing and Validating a Multimodal Brain Monitoring-Based Prognostic Model for Neurocritical Patients: A Prospective, Observational, Multicenter Cohort Study

Overview

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.

Primary outcome measures

  • 90-day Outcome Prediction [Time frame: 90-day]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07115459 · 2024070747-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗