Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:40 PM
Ignite Modification Date:
2025-12-24 @ 2:40 PM
NCT ID:
NCT07115459
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07115459
Study Brief:
Protocol Section:
NCT07115459