The Albumin in Acute Stroke Trial (ALIAS); Design and methodology

Michael D. Hill, Claudia S. Moy, Yuko Y. Palesch, Renee Martin, Catherine R. Dillon, Bonnie Darcy Waldman, Lynn Patterson, Isabel M. Mendez, Karla J. Ryckborst, Diego Tamariz, Myron D. Ginsberg

Research output: Contribution to journalArticle

18 Scopus citations

Abstract

Stroke is a serious global illness. Human albumin has emerged as a putative therapy for ischaemic stroke based on strong evidence from animal models. Following confirmation of the safety and feasibility of high-dose albumin treatment for acute ischaemic stroke in a pilot study, the Albumin in Acute Stroke trial, a phase 3 randomised, double-blinded, placebo-controlled clinical trial was initiated to evaluate the efficacy of high-dose albumin compared to saline control within 5 h of ischaemic stroke onset. Methods: The trial will enrol 1800 patients in two cohorts - a thrombolytic and a nonthrombolytic arm. High-dose (2g/kg) human albumin will be administered in a 2-h straight intravenous infusion to ischaemic stroke patients, within 5h of symptom onset. The primary outcome will be an NIH stroke scale score of 0-1 or a modified Rankin scale score of 0-1 at 90 days. Safety outcomes will include the incidence of congestive heart failure after study-drug administration. Results: Enrolment opened at 40 sites in August 2006; new sites continue to be added. Recruitment is ongoing and is projected to be completed by 2010. Conclusions: The trial will continue through 2010. The study is proceeding as planned.

Original languageEnglish (US)
Pages (from-to)214-219
Number of pages6
JournalInternational Journal of Stroke
Volume2
Issue number3
DOIs
StatePublished - Aug 1 2007

Keywords

  • Albumin
  • Ischaemic stroke
  • Randomised-clinical trials

ASJC Scopus subject areas

  • Neurology

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    Hill, M. D., Moy, C. S., Palesch, Y. Y., Martin, R., Dillon, C. R., Waldman, B. D., Patterson, L., Mendez, I. M., Ryckborst, K. J., Tamariz, D., & Ginsberg, M. D. (2007). The Albumin in Acute Stroke Trial (ALIAS); Design and methodology. International Journal of Stroke, 2(3), 214-219. https://doi.org/10.1111/j.1747-4949.2007.00143.x