Treatment of subarachnoid hemorrhage with human albumin: ALISAH study. Rationale and design

Abstract

The primary objective of this prospective dose-finding pilot study is to demonstrate the tolerability and safety of four dosages of 25% human albumin in patients with subarachnoid hemorrhage (SAH). For each dosage group, the study will enroll 20 patients who meet the eligibility criteria. The enrolled patients will undergo follow-up for 90 days post-treatment. The primary tolerability hypothesis is that intravenous 25% human albumin can be given without precipitating treatment related serious adverse events beyond expectations. The study will determine the maximum tolerated dosage of 25% human albumin therapy based on the rate of treatment related serious adverse events during treatment: severe or life-threatening heart failure. The secondary objectives are to obtain preliminary estimates of the albumin treatment effect using the incidence of neurological deterioration within 15 days after symptom onset. In addition, the incidence of rebleeding, hydrocephalus, seizures, delayed cerebral ischemia and the incidence of vasospasm (both symptomatic and by transcranial Doppler ultrasound criteria) within 15 days after symptom onset will be evaluated. Furthermore, the serum osmolality and serum albumin concentrations, serum magnesium concentration, blood pressure and heart rate within 15 days of symptom onset will also be observed. The Glasgow Outcome Scale, Barthel Index, modified Rankin Scale, NIH Stroke Scale, and Stroke Impact Scale will be performed 3 months after the onset of symptoms to assess residual neurological deficits.