Status:
NOT_YET_RECRUITING
Non-invasive Intracranial Pressure Monitoring to Improve Emergency Care in Brazil's Public Health System
Lead Sponsor:
Braincare USA Corp
Collaborating Sponsors:
Universidade Federal de Sergipe
Federal University of São Paulo
Conditions:
Traumatic Brain Injury (TBI) Patients
Stroke Hemorrhagic
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this observational study is to evaluate the diagnostic accuracy of non-invasive intracranial pressure (ICP) and intracranial compliance (ICC) pulse morphology and associated parameters (su...
Detailed Description
This is a prospective, observational, multicenter, longitudinal cohort study conducted in four Brazilian states (Amazonas, São Paulo, Sergipe, and Rio Grande do Sul). The study aims to evaluate the di...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients of both sexes.
- Age ≥ 18 years.
- Clinical signs and symptoms of traumatic brain injury (mild, moderate, or severe) or stroke (ischemic or hemorrhagic).
- Signed informed consent form by the patient or by a legally authorized representative in cases where the patient is unable to consent due to the severity of the clinical condition. If the legal representative is not present at the time of admission or initial care, consent may be obtained retrospectively.
- Exclusion Criteria
- Individuals with brain lesions of other etiologies, such as previous TBI and/or stroke, neoplasms, infections, sepsis, arteriovenous malformation, intoxication, or illicit drug use.
- Individuals with scalp or skin lacerations that prevent proper placement of the brain4care sensor.
- Individuals with craniectomy or skull fractures.
- Individuals with severe debilitating mental health disorders and/or severe debilitating neurological diseases.
- Individuals who are agitated, aggressive, or uncooperative, preventing follow-up and outcome assessment.
- Pregnant women.
Exclusion
Key Trial Info
Start Date :
December 16 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 28 2028
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07210333
Start Date
December 16 2025
End Date
January 28 2028
Last Update
October 7 2025
Active Locations (3)
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1
Hospital Universitário Getúlio Vargas
Manaus, Amazonas, Brazil, 69020-170
2
Hospital Universitário de Lagarto
Lagarto, Sergipe, Brazil, 49400-000
3
Hospital São Paulo
São Paulo, São Paulo, Brazil, 04024-002