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Randomized Controlled Trial
. 2016 Sep;47(9):2355-9.
doi: 10.1161/STROKEAHA.116.012825. Epub 2016 Jul 26.

ALIAS (Albumin in Acute Ischemic Stroke) Trials: Analysis of the Combined Data From Parts 1 and 2

Renee' H Martin  1 , Sharon D Yeatts  2 , Michael D Hill  2 , Claudia S Moy  2 , Myron D Ginsberg  2 , Yuko Y Palesch  2 ; ALIAS Parts 1 and 2 and NETT Investigators
Affiliations
Randomized Controlled Trial

ALIAS (Albumin in Acute Ischemic Stroke) Trials: Analysis of the Combined Data From Parts 1 and 2

Renee' H Martin et al. Stroke. 2016 Sep.

Abstract

Background and purpose: The ALIAS (Albumin in Acute Ischemic Stroke) part 1 and 2 trials evaluated whether 25% human serum albumin improves clinical outcomes after acute ischemic stroke above and beyond standard of care using similar protocols. The part 1 trial ended prematurely because of safety concerns, and the part 2 trial terminated early because of futility of finding a statistically significant effect of albumin over saline (control) administration. We combine the subject-level data of the part 1 and 2 trials to reevaluate the efficacy and safety outcomes with the larger sample size.

Methods: The combined data analyses closely follow those conducted in the part 2 trial. The primary outcome is the composite of the modified Rankin Scale and the National Institutes of Health Stroke Scale defined as a composite of modified Rankin Scale score 0 to 1 and National Institutes of Health Stroke Scale score 0 to 1 at 90 days from randomization. The unadjusted analyses use a simple Chi-square test, and those adjusting for baseline covariates use a generalized linear model with log link (to obtain relative risks).

Results: The participant characteristics at baseline were generally similar between the treatment groups and between the trials; however, thrombolysis use was greater in part 2 (84% versus 75%), and the upper age limit imposed in part 2 resulted in a younger sample (mean age in part 1 was 69 versus 64 in part 2). In the combined sample, the proportions of good outcome in the 2 treatment groups were identical (41%). Similar results were observed in all secondary efficacy outcomes. Pulmonary edema was a consistent safety concern, with a 6-fold increase in the albumin arm (13%) compared with saline (2%; relative risk =7.76, 95% confidence interval 3.87-15.57).

Conclusions: Treatment with intravenous albumin 25% at 2 g/kg was not associated with improved outcome at 90 days and was associated with increased rates of intracerebral hemorrhage and pulmonary edema.

Clinical trial registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00235495.

Keywords: acute stroke; albumin; randomized trial; risk; serum albumin.

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Figures

Figure 1
Figure 1
Cumulative Efficacy: Parts 1 and 2 Combined
Figure 2
Figure 2
Distribution of 90-day MRS Scores by Treatment
Figure 3
Figure 3
Impact of Treatment on Safety Events by Trial Part
See this image and copyright information in PMC

References

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