The albumin in acute stroke part 1 trial: An exploratory efficacy analysis

Michael D. Hill, Renee H. Martin, Yuko Y. Palesch, Diego Tamariz, Bonnie D. Waldman, Karla J. Ryckborst, Claudia S. Moy, William G. Barsan, Myron D. Ginsberg

Research output: Contribution to journalArticle

47 Scopus citations

Abstract

Background And Purpose- 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.

Original languageEnglish (US)
Pages (from-to)1621-1625
Number of pages5
JournalStroke
Volume42
Issue number6
DOIs
StatePublished - Jun 1 2011

Keywords

  • acute treatment
  • adjuvant stroke therapy
  • ischemic stroke albumin
  • neuroprotection

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Clinical Neurology
  • Advanced and Specialized Nursing

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    Hill, M. D., Martin, R. H., Palesch, Y. Y., Tamariz, D., Waldman, B. D., Ryckborst, K. J., Moy, C. S., Barsan, W. G., & Ginsberg, M. D. (2011). The albumin in acute stroke part 1 trial: An exploratory efficacy analysis. Stroke, 42(6), 1621-1625. https://doi.org/10.1161/STROKEAHA.110.610980