The Albumin in Acute Stroke Part 1 Trial: an exploratory efficacy analysis.
Author(s): Hill MD, Martin RH, Palesch YY, Tamariz D, Waldman BD, Ryckborst KJ, Moy CS,
Barsan WG, Ginsberg MD; ALIAS Investigators; Neurological Emergencies Treatment
Trials Network.
Affiliation(s): Calgary Stroke Program, Department of Clinical Neurosciences, University of
Calgary, Foothills Hospital, Room 1242A, 1403 29th St. NW, Calgary, Alberta, T2N
2T9, Canada. michael.hill@ucalgary.ca
Publication date & source: 2011, Stroke. , 42(6):1621-5
BACKGROUND AND PURPOSE: The Albumin in Acute Stroke (ALIAS) Part 2 Trial is
directly testing whether 2 g/kg of 25% human albumin (ALB) administered
intravenously within 5 hours of ischemic stroke onset results in improved
clinical outcome. Recruitment into Part 1 of the ALIAS Trial was halted for
safety reasons. ALIAS Part 2 is a new, reformulated trial with more-stringent
exclusion criteria. Our aim was to explore the efficacy of ALB in the ALIAS Part
1 data and to assess the statistical assumptions underlying the ALIAS Part 2
Trial.
METHODS: ALIAS is a multicenter, blinded, randomized controlled trial. Data on
434 subjects, comprising the ALIAS Part 1 subjects, were analyzed. We examined
both the thrombolysis and nonthrombolysis cohorts combined and separately in a
"target population" by excluding subjects who would not have been eligible for
the ALIAS Part 2 Trial; the latter comprised patients >83 years of age, those
with elevated baseline troponin values, and those with in-hospital stroke. We
examined the differences in the primary composite outcome, defined as a modified
Rankin Scale score of 0 to 1 and/or a National Institutes of Health Stroke Scale
score of 0 to 1 at 90 days after randomization.
RESULTS: In the combined thrombolysis plus nonthrombolysis cohorts of the target
population, 44.7% of subjects in the ALB group had a favorable outcome compared
with 36.0% in the saline group (absolute effect size=8.7%; 95% CI, -2.2% to
19.5%). Among thrombolyzed subjects of the target population, 46.7% had a
favorable outcome in the ALB group compared with 36.6% in the saline group
(absolute effect size=10.1%; 95% CI, -2.0% to 20.0%).
CONCLUSIONS: Preliminary results from the ALIAS Part 1 suggest a trend toward a
favorable primary outcome in subjects treated with ALB and support the validity
of the statistical assumptions that underlie the ALIAS Part 2 Trial. The ALIAS
Part 2 Trial will confirm or refute these results.
CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov/ALIAS. Unique
identifier: NCT00235495.
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