The albumin in acute stroke trial (ALIAS); design and methodology

Int J Stroke. 2007 Aug;2(3):214-9. doi: 10.1111/j.1747-4949.2007.00143.x.


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 (2 g/kg) human albumin will be administered in a 2-h straight intravenous infusion to ischaemic stroke patients, within 5 h 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.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Albumins / administration & dosage*
  • Double-Blind Method
  • Fibrinolytic Agents / administration & dosage
  • Humans
  • Research Design*
  • Stroke / drug therapy*
  • Tissue Plasminogen Activator / administration & dosage


  • Albumins
  • Fibrinolytic Agents
  • Tissue Plasminogen Activator