Construction of a Prognostic Model for Severe Brain-Injured Patients Based on Integrated Metabolic-Neurological Monitoring

This is a prospective, observational cohort study aimed at constructing a machine learning-based prognostic model for severe brain-injured patients. The study will synchronously collect continuous glucose monitoring (CGM), electroencephalography (EEG), near-infrared spectroscopy (fNIRS), transcranial Doppler (TCD), and serum neuronal injury biomarkers (NSE, S100β) within 72 hours post-injury. The goal is to investigate the correlation between glycemic variability (GV) and neurological function and to develop an integrated model for early prediction of 3-6 month neurological outcomes (GOSE score).

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Key information

Conditions

Brain Injuries Brain Diseases Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

This study intends to enroll 50 adult patients with brain injury admitted to the ICU. Multimodal monitoring data will be collected prospectively. Machine learning algorithms will be used to integrate the data and build a predictive model. The study will test whether integrated metabolic-neurological monitoring outperforms traditional single-parameter prognostic methods.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of severe TBI, large-volume stroke, or HIE
Expected ICU stay >72 hours
Informed consent from legal surrogate

Exclusion criteria

Terminal organ failure
Pre-existing severe neurological disease
Skull defect preventing monitoring
Pregnancy or lactation

Treatment and study plan

Primary outcomes

Glasgow Outcome Scale Extended (GOSE)

Time frame: 3 and 6 months

Neurological outcome at 3 and 6 months assessed by Glasgow Outcome Scale Extended (GOSE)

Secondary outcomes

28 days mortality

Time frame: 28 days

all cause mortality at days 28

Study contacts

Contact information is provided by the study sponsor or research team.

Xingui Dai

CONTACT

[email protected]

18175708210

Sponsors and collaborators

Lead sponsor

Xingui Dai

Other

Registry information

Official study title

Construction of a Prognostic Model for Severe Brain-Injured Patients Based on Integrated Metabolic-Neurological Monitoring: A Prospective Observational Study

Acronym: CPM-Brain

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Sep 30, 2025
Registry last updated: Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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