The ALIAS Pilot Trial. A dose-escalation and safety study of albumin therapy for acute ischemic stroke - I: Physiological responses and safety results

Myron D. Ginsberg, Michael D. Hill, Yuko Y. Palesch, Karla J. Ryckborst, Diego Tamariz

Research output: Contribution to journalArticle

101 Scopus citations

Abstract

BACKGROUND AND PURPOSE - In preclinical stroke models, high-dose human albumin confers robust neuroprotection. We investigated the safety and tolerability of this therapy in patients with acute ischemic stroke. METHODS - The ALIAS (Albumin in Acute Stroke) Pilot Clinical Trial used a multiple-tier, open-label, dose-escalation design. Subjects with acute ischemic stroke (NIH Stroke Scale [NIHSS] of 6 or above) received a 2-hour infusion of 25% human albumin (ALB) beginning within 16 hours of stroke onset. Six successive ALB dose tiers were assessed ranging from 0.34 to 2.05 g/kg. Neurologic and cardiac function was sequentially monitored. At 3 months, the NIHSS, modified Rankin Scale, and Barthel Index were measured. RESULTS - Eighty-two subjects (mean age, 65 years) received ALB at 7.8±3.4 hours after stroke onset (mean±standard deviation). Forty-two patients also received standard-of-care intravenous tissue plasminogen activator (tPA). Vital signs were unaltered by ALB treatment. Dose-related increases in plasma albumin and mild hemodilution were maximal at 4 to 12 hours. Age-related plasma brain natriuretic peptide levels increased at 24 hours after ALB but did not predict cardiac adverse events. The sole ALB-related adverse event was mild or moderate pulmonary edema in 13.4% of subjects, which was readily managed with diuretics. In the tPA-treated subgroup, symptomatic intracranial hemorrhage occurred in only one of 42 subjects. CONCLUSIONS - Twenty-five percent human albumin in doses ranging up to 2.05 g/kg was tolerated by patients with acute ischemic stroke without major dose-limiting complications. tPA therapy did not affect the safety profile of ALB. The companion article presents neurologic outcome data and efficacy analysis in these subjects.

Original languageEnglish (US)
Pages (from-to)2100-2106
Number of pages7
JournalStroke
Volume37
Issue number8
DOIs
StatePublished - Aug 1 2006

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Keywords

  • Ischemia
  • Neuroprotection
  • Outcome
  • Stroke
  • Thrombolysis

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Neuroscience(all)

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