An observational study in Subarachnoid Hemorrhage, Intracerebral Hemorrhage and Traumatic Brain Injury, sponsored by Medical University of Vienna. Recruiting at 1 site in Austria. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-02-03.
Sponsored by Medical University of Vienna · Observational
Theoretical Framework \& Background
Cortical spreading depressions (CSD) and seizures, are crucial in the development of delayed cerebral ischemia and poor functional outcome in patients suffering from acute brain injuries such as subarachnoid hemorrhage. Multimodal neuromonitoring (MMNM) provides the unique possibility in the sedated and mechanically ventilated patients to record these electrophysiological phenomena and relate them to measures of cerebral ischemia and malperfusion. MMNM combines invasive (e.g. electrocorticography, cerebral microdialysis, brain tissue oxygenation) and noninvasive (e.g. neuroimaging, continuous EEG) techniques. Additionally, cerebral microdialysis can measure the unbound extracellular drug concentrations of sedatives, which potentially inhibit CSD and seizures in various degrees, beyond the blood-brain barrier without further interventions.
Hypotheses
Methods
Systematic analysis of MMNM measurements following standardized criteria and correlation of electrophysiological phenomena with cerebral metabolic changes in all included patients. In a second step neuroimaging, cerebral extracellular sedative drug concentrations and neurological functional outcome, will be correlated with both electrophysiologic and metabolic changes. Due to numerous high-resolution parameters, machine learning algorithms will be used to correlate comprehensive data on group and individual levels following a holistic approach.
Level of originality
Extensive, cutting edge diagnostic methods are used to get a better insight into the pathophysiology of electrophysiological and metabolic changes during the development of secondary brain damage. Due to the immense amount of high-resolution data, a computer-assisted evaluation will be applied to identify relationships in the development of secondary brain injury. For the first time systematic testing of several drug concentrations beyond the blood-brain barrier will be performed. With these combined methods, we will be able to develop new cerebroprotective treatment concepts on an individual basis.
2,113 studies on the registry are indexed under Brain Injuries; 384 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 689 observational studies indexed under Brain Injuries.
Browse Brain Injuries studies →Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Individuals between 18-80 years with poor grade aneurysmal SAH (World Federation Neurosurgical Societies >3), severe ICH (ICH Score >3) or severe TBI (Glasgow Coma Scale \<9).
Exclusion Criteria:
Thereafter, the patient has the possibility to withdraw permission of study-participation.
Count of SD during electrocorticography
Count of cortical spreading depolarization (SD) during continuous electrocorticography
Time frame: up to 21 days
Daily pattern duration of CSD during electrocorticography
Duration of cortical spreading depression (CSD) per hour during continuous electrocorticography
Time frame: up to 21 days
Daily pattern duration of NCSE during electrocorticography
Duration of nonconvulsive status epilepticus (NCSE) per hour during continuous electrocorticography
Time frame: up to 21 days
Daily pattern duration of RPPIIC during electrocorticography
Duration of rhythmic or periodic EEG patterns on the ictal-interictal continuum (RPPIIC) per hour during continuous electrocorticography
Time frame: up to 21 days
Daily duration of metabolic crisis
Duration of metabolic crisis (defined as Lactate Pyruvate ratio \[LPR\] \> 40 and lactate higher than 4 mmol/l) during continuous electrocorticography
Time frame: up to 21 days
Daily duration of mitochondrial dysfunction
Duration of mitochondrial dysfunction (defined as LPR \> 40, Pyruvate \> 70 μmol/l and partial brain tissue oxygenation \[PbtO2\] \> 20 mmHg) during continuous electrocorticography
Time frame: up to 21 days
Daily duration of ischemia
Duration of ischemia (defined as PbtO2 \< 15 mmHg and cerebral perfusion pressure \[CPP\] \< 60 mmHg) during continuous electrocorticography
Time frame: up to 21 days
Daily duration of elevated intracranial pressure (ICP)
Duration of elevated intracranial pressure (defined as ICP \> 22 mmHg) during continuous electrocorticography
Time frame: up to 21 days
Neuropharmacology Cmax)
Cmax of routinely used sedative drug concentrations in blood and brain (Esketamine, Midazolam and Propofol)
Time frame: up to 21 days
Neuropharmacology (AUC)
AUC of routinely used sedative drug concentrations in blood and brain (Esketamine, Midazolam and Propofol)
Time frame: up to 21 days
Neuropharmacology (t1/2)
t1/2 of routinely used sedative drug concentrations in blood and brain (Esketamine, Midazolam and Propofol)
Time frame: up to 21 days
Neuroimaging
Absence or presence of hypoperfusion or ischemic infarctions in neuroimaging
Time frame: up to 28 days
Functional patient outcome
modified Rankin Scale
Time frame: up to 6 months
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Medical University of Vienna