The albumin in acute stroke trial (ALIAS); design and methodology.
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.
Hill
Michael D
MD
Department of Clinical Neurosciences, Calgary Stroke Program, Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada. michael.hill@calgaryhealthregion.ca
Moy
Claudia S
CS
Palesch
Yuko Y
YY
Martin
Renee
R
Dillon
Catherine R
CR
Waldman
Bonnie Darcy
BD
Patterson
Lynn
L
Mendez
Isabel M
IM
Ryckborst
Karla J
KJ
Tamariz
Diego
D
Ginsberg
Myron D
MD
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
D000418:Albumins; D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator