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Table 1 Secondary objectives and endpoints

From: Stereotactic cisternal lavage in patients with aneurysmal subarachnoid hemorrhage with urokinase and nimodipine for the prevention of secondary brain injury (SPLASH): study protocol for a randomized controlled trial

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
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Trials

ISSN: 1745-6215

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