Ginsberg MD et al. (2006) The ALIAS Pilot Trial: a dose-escalation and safety study of albumin therapy for acute ischemic stroke—I: physiological responses and safety results. Stroke 37: 2100–2106

Palesch YY et al. (2006) The ALIAS Pilot Trial: a dose-escalation and safety study of albumin therapy for acute ischemic stroke—II: neurologic outcome and efficacy analysis. Stroke 37:2107–2114

Promising results were recently reported for the ALIAS (Albumin in Acute Stroke) Pilot Trial—a phase I, open-label, dose-escalation study investigating use of high-dose human albumin (ALB) for the treatment of acute ischemic stroke. ALB has previously been shown to have strong neuroprotective properties in rodent models of stroke.

A total of 82 patients with acute ischemic stroke participated in the study. Six successive cohorts received an infusion of 25% ALB within 16 h of stroke onset, with dose tiers increasing from 0.34 g/kg to 2.05 g/kg. Forty-two of the patients also received intravenous tissue plasminogen activator—the current standard of care for acute ischemic stroke.

In addition to regular monitoring of vital signs, patients underwent regular cardiac evaluation and were given brain CT scans and chest X-rays after treatment. Patients were assigned NIHSS (NIH stroke scale) scores at baseline, at regular intervals during the first 72 h after treatment, at discharge and 1 month after discharge. At 3 months post-discharge, efficacy outcomes were determined using the NIHSS scale, modified Rankin scale (mRS) and Barthel Index.

After adjustment for the effects of tissue plasminogen activator, the probability of a good outcome at 3 months (defined as an NIHSS score of 0–1 and/or an mRS score of 0–1) for the three highest ALB doses was found to be 81% higher than for the three lowest doses, and 95% higher than for comparable patients from the NINDS rt-PA Stroke Study. The only adverse event was mild to moderate pulmonary edema, which occurred in 13% of subjects and was successfully managed with diuretics.

On the basis of these results, a large phase III trial is now underway, and is expected to conclude in 2010.