Development and Validation of a Prognostic Model for Neurocritical Patients Using Multimodal Brain Monitoring
Launched by XIANGYA HOSPITAL OF CENTRAL SOUTH UNIVERSITY · Aug 3, 2025
Trial Information
Current as of August 20, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how to better predict outcomes for patients with serious brain injuries, such as severe strokes, bleeding in the brain, or traumatic brain injuries. The researchers plan to use different types of brain monitoring tools together—like tests that measure brain activity, blood flow, and oxygen levels—to create a model that can help doctors understand a patient’s chances of waking up, remaining in a coma, or passing away within 90 days. This model aims to support doctors in making more personalized treatment decisions for patients in intensive care.
People who may be eligible to participate are adults between 18 and 80 years old who have recently suffered a severe brain injury and are admitted to the ICU with very limited eye and motor responses, meaning they are not opening their eyes and have little or no movement. Participants must be able to undergo continuous brain monitoring for at least three days. The study only observes patients and does not involve any new treatments or procedures. Families or legal representatives will be asked to give consent before participation. This study is not yet recruiting but hopes to help improve how doctors predict recovery for patients with critical brain injuries.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Aged 18-80 years, no gender restrictions.
- • 2. 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.
- • 3. 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).
- • 4. Able to undergo continuous multimodal monitoring, with an expected ICU stay of ≥72 hours.
- • 5. Informed consent signed by the family or legal representative.
- Exclusion Criteria:
- • 1. Confirmed brain death on admission or imaging showing irreversible brain herniation.
- • 2. 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.
- • 3. Pre-existing severe neurological disorders such as epilepsy, severe encephalopathy, or chronic intracranial conditions (e.g., brain tumors or hydrocephalus).
- • 4. Inability to perform multimodal monitoring due to technical issues (e.g., equipment failure or sensor installation problems).
- • 5. Predicted survival time \<24 hours after admission, or family members choose to withdraw treatment.
- • 6. Refusal to participate in the study by the patient or their legal representative.
About Xiangya Hospital Of Central South University
Xiangya Hospital of Central South University is a leading academic medical institution located in Changsha, China, renowned for its commitment to advancing healthcare through innovative clinical research and patient-centered care. As a key affiliate of Central South University, the hospital integrates clinical practice with medical education and research, fostering an environment that promotes the development of cutting-edge therapies and treatments. With a diverse array of specialized departments and a dedicated team of healthcare professionals, Xiangya Hospital actively participates in clinical trials aimed at enhancing medical knowledge and improving patient outcomes, contributing significantly to the global medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported