Efficacy and safety of albumin combined with endovascular therapy in the treatment of patients with acute ischemic stroke: a randomized clinical trial.

The safety and efficacy of albumin combined with endovascular therapy for participants with acute ischemic stroke is unknown. This randomized, double blinded, multicenter study was conducted in China and completed in 2025. Eligible participants were randomly assigned in a 1:1 ratio to albumin group (0.5 g/kg; maximum dose 150 mL; intravenously infusion once daily for 4 days) or placebo group (equivalent volume of placebo). The primary endpoint was the change in infarct volume from baseline to day 5. A total of 134 patients were randomized (66 in albumin group and 68 in placebo group) and 134 patients were included in the final analysis. Albumin reduced infarct volume growth from baseline to day 5 compared with placebo (median growth 7.5 mL vs 16.5 mL, adjusted median difference -8.63, 95%CI (-13.85 to -5.07); P = 0.003). The safety outcomes did not differ between the two groups. This work suggests that albumin plus endovascular therapy could significantly reduce infarct volume growth compared with the placebo group, without raising safety concerns. (Funded by the National Natural Science Foundation of China and others; ClinicalTrials.gov registration: NCT06538844.).