Optimal Cerebral Perfusion Pressure Guided Therapy: Assessment of Target Effectiveness - II

Sponsor
Maastricht University Medical Center
Study ID
NCT07287358
Status
Not Yet Recruiting

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Conditions

  • Cerebral Perfusion Pressure
  • Intracranial Pressure
  • Severe Traumatic Brain Injury
  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Optimal cerebral perfusion pressure — OTHER
    The intervention group will receive CPPopt guided management with updated CPPopt targets every 4 hours. All other parameters will be handled according to Brain Trauma Foundation (BTF) guidelines.

Study Details

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.

Key Dates

First listed
Dec 17, 2025
Start date
May 1, 2026
Status verified
Dec 2025
Primary completion
May 1, 2028
Completion
May 15, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: CPPopt treatment
    The CPPopt treatment group will receive management according to the Brain Trauma Foundation (BTF) guidelines, except for the targeted cerebral perfusion pressure. Here, the calculated "optimal cerebral perfusion pressure (CPPopt)" will be targeted, with updated CPPopt targets every 4 hours.
  • No Intervention: Control group
    The intervention group will receive standard brain trauma management according to the Brain Trauma Foundation (BTF) guidelines, including the standard cerebral perfusion pressure target of 60-70 mmHg.

Primary Outcome Measure

Cumulative concentration of blood biomarker Glial Fibrillary Acidic Protein (GFAP) during first 5 days of ICU admission [ Time Frame: The first 5 days of ICU admission ]

Central Contacts

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