Table 1 Secondary objectives and endpoints
Secondary objectives | Secondary endpoints |
|---|---|
To assess the effect of the IT on neuropsychological outcome | Neuropsychological outcome at 6 months following aSAH: - Cognitive performance (Montreal Cognitive Assessment) - Health-related quality of life (SF-36) - Fatigue, anxiety, and depressive symptoms (Frontal Systems Behavior Scale, Multidimensional Assessment of Fatigue, Hospital Anxiety and Depression Scale) - Post-traumatic stress disorder (Impact of Event Scale–R) Return-to-work parameters at 6 months |
To assess the effect of the IT on DCI | Rate and severity of DCI according to the Vergouwen criteria |
To assess the effect of the IT on delayed ischemic neurological deficits (DIND) after aSAH | Rate of delayed ischemic neurological deficit (DIND), defined as clinical deterioration caused by delayed cerebral ischemia (i.e., a new focal neurological deficit or decline on the Glasgow Coma Scale of 1 point not attributable to other causes) on days 3–21 |
To assess the effect of the IT on the development of post-hemorrhagic hydrocephalus | Rates of shunt-dependent hydrocephalus at 6 months following aSAH |
To assess the effect of the IT on sonographic vasospasm | Delta mean flow velocities of both middle cerebral arteries—measured by transcranial Doppler ultrasonography on days 3–21 |
To assess the effect of the IT on the need for endovascular interventions for the treatment of cerebral vasospasm | Rate of endovascular interventions for the treatment of cerebral vasospasm |
To assess the effect of the IT on the course of intensive care therapy | Key parameters of intensive care medicine (Sequential Organ Failure Score) |
To assess the effect of the IT on morphological brain damage | Morphological brain damage at 6 months after aSAH as assessed by MRI |
To assess the effect of the IT on further clinical and surrogate outcomes | NIHSS score at days 3–21 and at 6 months |
Key parameters of endocrinological dysfunction | |
Key markers of neuronal injury and systemic inflammation in patient blood | |
Electroencephalographic patterns as measured by continuous EEG monitoring during intensive care period (exploratory endpoint) | |
To assess the safety of the IT | Safety of IT: (serious) adverse events related to the IT |