Development and Validation of a Prognostic Model for Neurocritical Patients Using Multimodal Brai… (NCT07115459) | Clinical Trial Compass
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Development and Validation of a Prognostic Model for Neurocritical Patients Using Multimodal Brain Monitoring
167 participantsStarted 2025-08-15
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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.
What they're measuring
1
90-day Outcome Prediction
Timeframe: 90-day
Trial details
NCT IDNCT07115459
SponsorXiangya Hospital of Central South University