Post-traumatic brain hypoxia/ischemia develops hours after traumatic brain injury (TBI), and its intensity is directly related to the neurological outcome. The thresholds for irreversible tissue damage following TBI indicate a particular vulnerability of injured brain. Improving brain oxygenation after severe TBI is the focus of modern TBI management in the intensive care unit (ICU). The calculation of cerebral perfusion pressure (CPP), with CPP = mean arterial pressure (MAP) - intracranial pressure (ICP), has become the most used estimator of cerebral blow flow. To prevent ischemia due to elevated ICP, current international guidelines recommend maintaining CPP at 60-70 mmHg and ICP below 20 mmHg. However, episodes of brain hypoxia/ischemia, as assessed with brain tissue oxygen pressure (PbtO2) measurements, might occur despite optimization of CPP and ICP, and have been independently associated with poorer patient outcome. PbtO2 values lower than 15 mmHg for more than 30 minutes were shown to be an independent predictor of unfavorable outcome and death. The aggressive treatment of low PbtO2 was associated with improved outcome compared to standard ICP/CPP-directed therapy in cohort studies of severely head-injured patients. On the basis of these findings, it is hypothesized that an early optimization of brain oxygenation, together with keeping ICP and CPP within recommended values, could reduce the volume of vulnerable lesions following severe TBI and possibly improve neurological outcome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
320
PbtO2/ICP/CPP-directed therapy according to international recommendations
ICP/CPP-directed therapy according to international recommendations
CHU Angers
Angers, France
General Hospital of Annecy
Annecy, France
University Hospital Besançon
Besançon, France
University Hospital of Bordeaux
Bordeaux, France
CHU CAEN
Caen, France
University Hospital of Clermont-Ferrand
Clermont-Ferrand, France
University Hospital of Dijon
Dijon, France
Grenoble University Hospital
Grenoble, France
University Hospital of Kremlin-Bicetre
Le Kremlin-Bicêtre, France
University Hospital of Lille
Lille, France
...and 16 more locations
Neurological outcome according to the extended Glasgow Outcome Scale (GOSE) blind assessed
Time frame: at 6 months post-trauma
Neurological outcome according to the extended Glasgow Outcome Scale (GOSE) and Disability Rating Scale
Time frame: at 12 months post-trauma (GOSE)
Disability Rating Scale (DRS)
Time frame: at 6 and 12 months post-trauma
Quality of life assessment: Functional Independence Measure (FIM) and Medical Outcomes Study Short-Form 12 (SF-12)
Time frame: at 6 and 12 months post-trauma
Mortality rate
Time frame: at day 28
Therapeutic intensity as reflected by the number of level 2 and level 3 treatments to treat elevated ICP
Time frame: during the first 5 days of the ICU stay
Incidence of critical events as defined by: ICP >30 mmHg during 30 min at least ICP >40 mmHg during 5 min at least PbtO2 <10 mmHg during 30 min at least (PbtO2 group)
Time frame: during the first 5 days of the ICU stay
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