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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMaastricht University Medical Center

About this trial

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

Qualifiers

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.

Disqualifiers

Known pregnancy

Moribund at presentation (e.g. bilaterally absent pupillary responses)

Patients with a primary decompressive craniectomy

Failure to get final written informed consent

Trial design

Treatments tested in this trial

  • Optimal cerebral perfusion pressure

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Maastricht University Medical Center

Lead sponsor

Medisch Spectrum Twente

Collaborator

Radboud University Medical Center

Collaborator

Medical Center Haaglanden

Collaborator