The ALIAS (ALbumin in Acute Stroke) Phase III randomized multicentre clinical trial: Design and progress report

M. D. Ginsberg, Y. Y. Palesch, M. D. Hill

Research output: Contribution to journalArticle

38 Scopus citations

Abstract

High-dose human ALB (albumin) therapy is highly neuroprotective in animal models of ischaemic stroke. A recently completed 82-subject pilot-phase dose-escalation trial has shown that ALB is safe, with strong preliminary suggestions of possible efficacy. We are now proceeding to a large randomized, double-blinded, placebo-controlled multicentre trial funded by the NIH (National Institutes of Health), the ALIAS (Albumin In Acute Stroke) Phase III Trial, which is designed to ascertain definitively whether high-dose ALB therapy confers neuroprotection in subjects with acute ischaemic stroke treated within 5 h of stroke onset. The primary efficacy outcome measure is a favourable outcome, defined as an NIHSS (NIH Stroke Scale) score of 0-1 or a modified Rankin Scale score of 0-1 at 3 months post-randomization. Separate randomization (1:1) to ALB or placebo therapy will be carried out in two cohorts of 900 subjects each, one that receives standard-of-care thrombolytic therapy and the other that does not. Approx. 60 North American clinical sites will participate. Subject enrolment is expected to commence in July 2006.

Original languageEnglish (US)
Pages (from-to)1323-1326
Number of pages4
JournalBiochemical Society Transactions
Volume34
Issue number6
DOIs
StatePublished - Dec 1 2006

Keywords

  • Albumin
  • Focal cerebral ischaemia
  • Neuroprotection
  • Randomized clinical trial
  • Stroke
  • Thrombolysis

ASJC Scopus subject areas

  • Biochemistry

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