title: The albumin in acute stroke trial (ALIAS); design and methodology.
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 (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.
authors.affiliation: Department of Clinical Neurosciences, Calgary Stroke Program, Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada. michael.hill@calgaryhealthregion.ca
authors.forename: Michael D
authors.initials: MD
authors.lastname: Hill
authors.forename: Claudia S
authors.initials: CS
authors.lastname: Moy
authors.forename: Yuko Y
authors.initials: YY
authors.lastname: Palesch
authors.forename: Renee
authors.initials: R
authors.lastname: Martin
authors.forename: Catherine R
authors.initials: CR
authors.lastname: Dillon
authors.forename: Bonnie Darcy
authors.initials: BD
authors.lastname: Waldman
authors.forename: Lynn
authors.initials: L
authors.lastname: Patterson
authors.forename: Isabel M
authors.initials: IM
authors.lastname: Mendez
authors.forename: Karla J
authors.initials: KJ
authors.lastname: Ryckborst
authors.forename: Diego
authors.initials: D
authors.lastname: Tamariz
authors.forename: Myron D
authors.initials: MD
authors.lastname: Ginsberg
mesh_terms: D000418:Albumins / Q000008:administration & dosage*; D004311:Double-Blind Method; D005343:Fibrinolytic Agents / Q000008:administration & dosage; D006801:Humans; D012107:Research Design; D020521:Stroke / Q000188:drug therapy*; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage
chemical_list: D000418:Albumins; D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator