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The albumin in acute stroke trial (ALIAS); design and methodology
Michael D Hill1, Claudia S Moy, Yuko Y Palesch
1Department of Clinical Neurosciences, Calgary Stroke Program, Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada. michael.hill@calgaryhealthregion.ca
Unlabelled:
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.