Within this model we assessed the possible interaction of ALB and endovascular treatment, after adjusting for the prognostic variables listed above. We derived a multivariable model using logistic regression to obtain an adjusted estimate of effect size.
In the analysis of Strbian et al, 6 a SEDAN score of 3 would predict a sICH rate of ~11%. 6 The SEDAN score ranges from 0 to 6 and incorporates blood glucose level, early ischemic signs and hyperdense cerebral artery sign on admission CT scan, age > 75 years, and NIHSS score of 10 or above. We also considered the SEDAN score to estimate the extent of sICH risk in patients receiving IV thrombolysis 5, 6 this score was derived 974 ischemic stroke patients and validated in another >800 subjects but did not include patients with endovascular therapy. We used the Mann-Whitney rank sum test and chi-square or Fisher’s exact test as appropriate. In univariate analyses, we compared baseline and treatment-related factors hypothesized to be possibly contributory to sICH development: age, baseline NIHSS score, baseline plasma glucose, study drug (ALB or SAL), use of IV tPA, use of endovascular thrombolysis, baseline ASPECTS score, and presence of hyperdense MCA sign on baseline neuroimaging. The data were derived from the trial’s Public Use Dataset. The present analysis was conducted on the protocol-defined “safety sample” of 830 subjects who had received at least 20% of the weight-based study-drug dose. A favorable primary outcome was defined as a score of 0 or 1 on either the NIHSS or the modified Rankin Scale (mRS), or both, at 90 days post-randomization. Exclusions were chiefly cardiovascular in nature. 1 In brief, subjects aged 18 through 83 with baseline National Institutes of Health Stroke Scale (NIHSS) scores of 6 or greater were randomized 1:1 to treatment with either 25% albumin (ALB, 2 g/kg) or a comparable volume of isotonic saline (SAL) started within 5 hours of stroke onset. The details of the trial’s design, inclusion and exclusion criteria, and outcomes have been reported previously.
In this report, we present a detailed analysis of both symptomatic and asymptomatic ICH in the ALIAS Part 2 trial and explore contributory factors. 3 Although the overall rate of symptomatic intracranial hemorrhage (sICH) within 24 hours of randomization (2.9%) was within the clinically acceptable range, 4 it was unexpectedly more frequent in subjects treated with albumin (ALB) than with saline-placebo (SAL) (relative risk 2.42, 95% CI 1.02–5.78). This was permitted by the trial’s protocol and was a concurrent secular evolution in acute stroke treatment.Īs albumin has properties potentially useful in preventing reperfusion injury, we suspected that ALB therapy might reduce sICH. As the trial progressed to Part 2, 2 endovascular stroke therapy was provided to an increasing proportion of stroke patients as part of routine care. Standard-of-care intravenous thrombolytic therapy with tPA (alteplase) was administered to 712 (85%) of the 841 subjects in the intent-to-treat population and 176 subjects (21%) received some form of endovascular thrombolytic intervention (mechanical and/or drug). As presented in the primary report of the trial’s results, 1 no overall clinical benefit was demonstrated. The ALIAS (Albumin in Acute Stroke) Part 2 multicenter clinical trial was a phase III, randomized placebo-controlled investigation to determine whether the early administration of high-dose human albumin would improve the neurological and functional outcome of patients with acute ischemic stroke.