Status:
RECRUITING
Non-Invasive Monitoring Methods in Patients With Acute Brain Injury
Lead Sponsor:
Boston Medical Center
Conditions:
Brain Injury, Acute
Eligibility:
All Genders
18+ years
Brief Summary
Life-threatening mass effect (LTME) arises when brain swelling displaces or compresses crucial midline structures subsequent to acute brain injuries (ABIs) like traumatic brain injury (TBI), ischemic ...
Eligibility Criteria
Inclusion
- Admitted under Neuro intensivist primary or consultative care.
- At least one head computed tomography (CT) scan demonstrating intracranial pathology that may lead to life-threatening mass effect (i.e. traumatic brain injury, ischemic or hemorrhagic stroke, epidural or subdural hematoma, subarachnoid hemorrhage, diffuse hypoxic injury, metabolic cerebral edema, tumor)
- Concern for Life Threatening Mass Effect
- Glasgow Coma Score (GCS) \<9
- Anticipated stay \>24 hours
Exclusion
- Comfort measure only
- Any other criteria that the PI deems that makes the patient inadequate for the study
- Sub-exclusion criteria for specific non-invasive measurements include:
- Orbital injury (pupillometry, ONSD)
- Traumatic injury or surgery that precludes use of B4C device
- Presence of supratentorial craniectomy or craniotomy that has not healed and is mobile/bone defects/scalp injury \[EEGelectroencephalogram (EEG), Brain4Care\]
- Presence of extensive scalp injury
Key Trial Info
Start Date :
September 26 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2030
Estimated Enrollment :
720 Patients enrolled
Trial Details
Trial ID
NCT06504238
Start Date
September 26 2024
End Date
September 1 2030
Last Update
October 29 2025
Active Locations (1)
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1
Boston Medical Center
Boston, Massachusetts, United States, 02118