title: The Albumin in Acute Stroke Part 1 Trial: an exploratory efficacy analysis.
abstract: OBJECTIVE
  The Albumin in Acute Stroke (ALIAS) Part 2 Trial is directly testing whether 2 g/kg of 25% human albumin (ALB) administered intravenously within 5 hours of ischemic stroke onset results in improved clinical outcome. Recruitment into Part 1 of the ALIAS Trial was halted for safety reasons. ALIAS Part 2 is a new, reformulated trial with more-stringent exclusion criteria. Our aim was to explore the efficacy of ALB in the ALIAS Part 1 data and to assess the statistical assumptions underlying the ALIAS Part 2 Trial.
  
  
  METHODS
  ALIAS is a multicenter, blinded, randomized controlled trial. Data on 434 subjects, comprising the ALIAS Part 1 subjects, were analyzed. We examined both the thrombolysis and nonthrombolysis cohorts combined and separately in a "target population" by excluding subjects who would not have been eligible for the ALIAS Part 2 Trial; the latter comprised patients >83 years of age, those with elevated baseline troponin values, and those with in-hospital stroke. We examined the differences in the primary composite outcome, defined as a modified Rankin Scale score of 0 to 1 and/or a National Institutes of Health Stroke Scale score of 0 to 1 at 90 days after randomization.
  
  
  RESULTS
  In the combined thrombolysis plus nonthrombolysis cohorts of the target population, 44.7% of subjects in the ALB group had a favorable outcome compared with 36.0% in the saline group (absolute effect size=8.7%; 95% CI, -2.2% to 19.5%). Among thrombolyzed subjects of the target population, 46.7% had a favorable outcome in the ALB group compared with 36.6% in the saline group (absolute effect size=10.1%; 95% CI, -2.0% to 20.0%).
  
  
  CONCLUSIONS
  Preliminary results from the ALIAS Part 1 suggest a trend toward a favorable primary outcome in subjects treated with ALB and support the validity of the statistical assumptions that underlie the ALIAS Part 2 Trial. The ALIAS Part 2 Trial will confirm or refute these results.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov/ALIAS. Unique identifier: NCT00235495.
authors.affiliation: Calgary Stroke Program, Department of Clinical Neurosciences, University of Calgary, Foothills Hospital, Room 1242A, 1403 29th St. NW, Calgary, Alberta, T2N 2T9, Canada. michael.hill@ucalgary.ca
authors.forename: Michael D
authors.initials: MD
authors.lastname: Hill
authors.forename: Renee H
authors.initials: RH
authors.lastname: Martin
authors.forename: Yuko Y
authors.initials: YY
authors.lastname: Palesch
authors.forename: Diego
authors.initials: D
authors.lastname: Tamariz
authors.forename: Bonnie D
authors.initials: BD
authors.lastname: Waldman
authors.forename: Karla J
authors.initials: KJ
authors.lastname: Ryckborst
authors.forename: Claudia S
authors.initials: CS
authors.lastname: Moy
authors.forename: William G
authors.initials: WG
authors.lastname: Barsan
authors.forename: Myron D
authors.initials: MD
authors.lastname: Ginsberg
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000418:Albumins / Q000627:therapeutic use*; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D020521:Stroke / Q000188:drug therapy*; D015912:Thrombolytic Therapy / Q000379:methods; D016896:Treatment Outcome
chemical_list: D000418:Albumins