3.5. Safety Analysis
intracranial hypertension, death, bleeding, vasospasm, ischemic stroke, empyema, deaths
MASSIVE HEMORRHAGE, BLEEDING, HEMORRHAGIC STROKE, VASOSPASM, ISCHEMIC STROKE, SECONDARY, EMPYEMA, COMPLICATIONS
The secondary complications that occurred during hospitalization are listed in Two deaths occurred that were not related to the current research. The first patient died due to “hemorrhagic stroke in relation to massive hemorrhage” 119 days after admission. For the primary endpoint, the absence of ischemic stroke on the last CT scan performed 2 months after bleeding was considered. The second patient’s death, due to “postoperative empyema of decompressive craniectomy, refractory intracranial hypertension”, occurred 70 days after admission. For the primary endpoint, the presence of ischemic stroke on MRI performed 6 weeks after initial bleeding was used. Symptomatic vasospasm occurred in two patients in the active stimulation group (7%) and three patients in the sham group (10%).