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Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Stroke 2016 ; 47 (9): 2355-9 Nephropedia Template TP
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Albumin in Acute Stroke (ALIAS) Trials: Analysis of the combined data from Parts 1 and 2 #MMPMID27462118
Martin RH; Yeatts SD; Hill MD; Moy CS; Ginsberg MD; Palesch YY
Stroke 2016[Sep]; 47 (9): 2355-9 PMID27462118show ga
BACKGROUND AND PURPOSE: The Albumin in Acute Stroke (ALIAS) 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 due to safety concerns, and the Part 2 Trial terminated early due to futility of finding a statistically significant effect of ALB over saline (control) administration. We combine the subject-level data of the Part 1 and 2 Trials to re-evaluate 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 NIH Stroke Scale defined as a composite of mRS 0-1 and/or NIHSS 0-1 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 Trials; however, thrombolysis use was greater in Part 2 (84% vs 75%), and the upper age limit imposed in Part 2 resulted in a younger sample (mean age in Part 1 was 69 vs 64 in Part 2). In the combined sample the proportions of good outcome in the two treatment groups were identical (41%). Similar results were observed in all secondary efficacy outcomes. Pulmonary edema was a consistent safety concern, with a six-fold increase in the ALB arm (13%) compared to Saline (2%) (RR=7.76, 95% CI 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.