Abstract T P49: Improving Outcome of Placebo- but not Albumin-Treated Subjects Over the Course of the ALIAS Part 2 Multicenter Trial: Differential Influence of Thrombolytic Therapy

In the ALIAS2 Trial, 841 subjects were randomized 1:1 to treatment with either 25% albumin (ALB, 2 g/kg) or normal saline within 5 hours of stroke onset, and the primary outcome (NIHSS 0-1 and/or modified Rankin scale 0-1) was assessed at 90 days. While overall outcomes did not differ by treatment (44% for both groups), we observed a steadily improving favorable rate in the saline-placebo arm but not in the ALB arm over the trial’s 3.5 year course. This was further analyzed here. Methods and Findings: Logistic regression confirmed a significant randomization-order x treatment interaction (p Conclusion: ALB treatment appears to have conferred a stable (and desirable) therapeutic “ceiling effect” throughout the trial (in the absence of significant toxicity), while saline subjects (who were unable to benefit from ALB) were susceptible to improved outcome from increasing tPA use as the trial progressed.