# Albumin for patients with acute large-vessel occlusive stroke undergoing endovascular therapy (ARISE): the protocol of a randomized double-blind trial

## TL;DR

This study tests if albumin therapy improves outcomes for stroke patients undergoing a specific treatment.

## Contribution

It introduces a randomized trial to evaluate albumin's role in acute stroke treatment.

## Key findings

- The trial will assess changes in infarct volume after albumin or placebo therapy.
- It aims to determine albumin's efficacy and safety in stroke patients receiving endovascular therapy.

## Abstract

Albumin is a multifunctional plasma protein that is mainly synthesized in the liver and may play a neuroprotective role in treating acute ischemic stroke (AIS). The efficacy of albumin in patients with AIS receiving reperfusion therapy remains unknown.

ARISE is a multicenter, randomized, double-blind, placebo-controlled, phase 2 study. We will recruit 134 patients aged 18–80 years with AIS due to large-vessel occlusion in the anterior circulation, within 24 h of symptom onset, with an Alberta Stroke Program Early CT Score of 3–10 points and an infarct core volume of ≤100 mL at baseline. Eligible patients will be randomly assigned, on a 1:1 ratio, to undergo endovascular therapy (EVT) and receive albumin therapy (0.5 g/kg; intravenous injection) once daily for 4 days or to undergo EVT and receive placebo therapy once daily for 4 days. The primary efficacy outcome is the change in infarct volume from baseline to day 5.

The ARISE trial will provide valuable evidence on the efficacy and safety of albumin in patients with AIS receiving EVT.

www.clinicaltrials.gov, NCT06538844.