The Albumin in Subarachnoid Hemorrhage (ALISAH) Multicenter Pilot Clinical Trial

• DOI: 10.1161/strokeaha.111.633958
• Publication Date: 2012-01-21T02:19:29Z
• Authors: Jose I. Suarez; Renee H. Martin; Eusebia Calvillo; Catherine Dillon; Eric M. Bershad; R. Loch MacDonald; John Wong; Robert Harbaugh
• Keywords: Tolerability; Dose; Dose-ranging study; Stroke

Background and Purpose— Human albumin has been shown to exert neuroprotective effects in animal models of cerebral ischemia humans with various intracranial pathologies. We investigated the safety tolerability 25% human patients subarachnoid hemorrhage. Methods— The Albumin Subarachnoid Hemorrhage (ALISAH) Pilot Clinical Trial was an open-label, dose-escalation study. intended study 4 different dosages increasing magnitude (0.625 g/kg: Tier 1; 1.25 2; 1.875 3; 2.5 4). Each dosage be given 20 adult patients. Treatment administered daily for 7 days. maximum tolerated dose based on rate severe-to-life-threatening heart failure anaphylactic reaction functional outcome at 3 months. Results— treated 47 subjects: 3. found that doses ranging up g/kg/day×7 days were by without major dose-limiting complications. also outcomes trended toward better responses those subjects enrolled 2 compared 1 (OR, 3.0513; CI, 0.6586–14.1367) International Intraoperative Hypothermia Aneurysm Surgery cohort 3.1462; 0.9158–10.8089). Conclusions— hemorrhage complications may neuroprotective. Based these results, planning ALISAH II, a Phase III, randomized, placebo-controlled trial test efficacy albumin, is underway. Registration— URL: http://clinicaltrials.gov . Unique identifier: NCT00283400.