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NCT07287358
Optimal Cerebral Perfusion Pressure Guided Therapy: Assessment of Target Effectiveness - II
Conditions: Traumatic Brain Injury, Severe Traumatic Brain Injury, Intracranial Pressure, Cerebral Perfusion Pressure
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 62
Sponsor: Maastricht University Medical Center
Location: Medisch Spectrum Twente Enschede
Summary
After severe traumatic brain injury, adequate blood flow to the brain is essential for recovery. This depends on arterial blood pressure, yet intensive care units apply fixed targets to all patients - treating every brain and patient the same. This study aims to change that. With new technology, 'optimal' blood pressure can be determined for each individual brain and treatment can be tailored accordingly. This personalized approach to neurocritical care has never been tested in a randomized controlled study before. If effective in showing reduced brain damage biomarkers, it will fundamentally transform brain injury treatment and dramatically improve recovery outcomes for patients worldwide.
Eligibility Criteria
Inclusion Criteria:
* Adult (\>18 years old)
* Severe TBI requiring ICP-directed therapy for at least 24 hrs on the assessment of the recruiting intensive care team and/or attending neurosurgeon
* Start randomization within 24 hrs after ICU admission.
Exclusion Criteria:
* Known pregnancy
* Moribund at presentation (e.g. bilaterally absent pupillary responses)
* Patients with a primary decompressive craniectomy
* Failure to get final written informed consent
Source: ClinicalTrials.gov (NCT07287358). StuddyBuddy aggregates publicly available trial information.