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.
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.
Known pregnancy
Moribund at presentation (e.g. bilaterally absent pupillary responses)
Patients with a primary decompressive craniectomy
Failure to get final written informed consent
Parallel
Optimal cerebral perfusion pressure
Other interventionThe 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. CPPopt treatment will be performed for a maximum of 5 days. If a patient still requires ICP treatment after 5 days, the standard, guideline-based treatment will be followed. CPPopt treatment can be shorter than 5 days, if ICP measurement is no longer required, if a patients wakes up, or if a patient dies.
Cumulative concentration of blood biomarker Glial Fibrillary Acidic Protein (GFAP) up to 14 days during ICU admission
The cumulative release of blood biomarker Glial Fibrillary Acidic Protein (GFAP) will be determined at ICU admission, and on day 1-5, 7 and 14 after ICU admission, but only as long as a patient is still on the ICU and has vascular access. GFAP will be quantified as the area under the curve (AUC) in both groups.
Cumulative concentrations of biomarkers NSE, UCH-L1, S100B, Tau and NfL up to 14 days of ICU admission
The cumulative release of five additional brain injury biomarkers: Neuron Specific Enolase (NSE), Ubiquitin C-terminal hydrolase L1 (UCH-L1), S100 calcium-binding protein B (S100B), Tau, and Neu-rofilament light chain (NfL) will be determined at ICU admission, and on day 1-5, 7 and 14 after ICU admission, but only as long as a patient is still on the ICU and has vascular access.
Progression of cerebral edema on CT imaging based on size of hypodense regions in sequential CT scans
Cerebral edema progression will be quantified by comparing brain CT scans obtained at admission with follow-up scans within the first five days of ICU admission (performed when clinically indicated).
Daily Therapy Intensity Level (TIL) score
Daily intracranial hypertenstion Therapy Intensity Level (TIL) score during the first five days on ICU to test whether our intervention reduces the need for aggressive treatment of increased ICP. Individual ICP-targeting therapies were assigned a score based on published estimates of their relative efficacy and risks of morbidity. The TIL includes eight ICP-treatment modalities, termed items. The maximum score is 38, with a higher score indicating that a patient is receiving more complex, aggressive, or frequent treatments.
Mean daily Pressure Reactivity Index (PRx) values
Mean daily Pressure Reactivity Index (PRx) values will be calculated as a global measure of cerebral autoregulation. PRx is defined as the moving correlation coefficient between slow waves of ABP and ICP, with more positive values indicating impaired autoregulation.
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Maastricht University Medical Center
Lead sponsor
Medisch Spectrum Twente
Collaborator
Radboud University Medical Center
Collaborator
Medical Center Haaglanden
Collaborator
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