Patients were split into two cohorts: those who received tpa (n=35) and those who did not (n=35). No significant differences were observed among the groups, however a dose-related trend toward clinical improvement was observed in patients within the tpa cohort, suggesting that high-dose ALB therapy may be neuroprotective after ischemic stroke. The probability of good outcome (defined as modified Rankin Scale 0 to 1 or NIH Stroke Scale 0 to 1 at 3 months) at the highest three ALB doses was 81% greater than in the lower dose-tiers (relative risk [RR], 1.81; 95% confidence interval [CI], 1.11 to 2.94) and was 95% greater than in the comparable NINDS rt-PA Stroke Study cohort (RR, 1.95; 95% CI, 1.47 to 2.57). The tPA-treated subjects who received higher-dose ALB were three times more likely to achieve a good outcome than subjects receiving lower-dose ALB, suggesting a positive synergistic effect between ALB and tPA. A larger, Phase II trial is being conducted.