Abstract
Stroke is a serious global illness. Human albumin has emerged as a putative therapy for ischaemic stroke based on strong evidence from animal models. Following confirmation of the safety and feasibility of high-dose albumin treatment for acute ischaemic stroke in a pilot study, the Albumin in Acute Stroke trial, a phase 3 randomised, double-blinded, placebo-controlled clinical trial was initiated to evaluate the efficacy of high-dose albumin compared to saline control within 5 h of ischaemic stroke onset. Methods: The trial will enrol 1800 patients in two cohorts - a thrombolytic and a nonthrombolytic arm. High-dose (2g/kg) human albumin will be administered in a 2-h straight intravenous infusion to ischaemic stroke patients, within 5h of symptom onset. The primary outcome will be an NIH stroke scale score of 0-1 or a modified Rankin scale score of 0-1 at 90 days. Safety outcomes will include the incidence of congestive heart failure after study-drug administration. Results: Enrolment opened at 40 sites in August 2006; new sites continue to be added. Recruitment is ongoing and is projected to be completed by 2010. Conclusions: The trial will continue through 2010. The study is proceeding as planned.
Original language | English (US) |
---|---|
Pages (from-to) | 214-219 |
Number of pages | 6 |
Journal | International Journal of Stroke |
Volume | 2 |
Issue number | 3 |
DOIs | |
State | Published - Aug 2007 |
Keywords
- Albumin
- Ischaemic stroke
- Randomised-clinical trials
ASJC Scopus subject areas
- Neurology