The albumin in acute stroke trial (ALIAS); design and methodology

International Journal of Stroke : Official Journal of the International Stroke Society
Michael D HillALIAS Investigators

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. The trial will enrol 1800 patients in two cohorts--a thrombolytic and a nonthrombolytic arm. High-dose (2 g/kg) human albumin will be administered in a 2-h straight intravenous infusion to ischaemic stroke patients, within 5 h 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. 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. The trial will continue through 2010. The study is proceeding as planned.

References

Jan 10, 2002·Stroke; a Journal of Cerebral Circulation·P LydenUNKNOWN CLASS-I/H/T Investigators
Apr 6, 2002·Stroke; a Journal of Cerebral Circulation·Ludmila BelayevMyron D Ginsberg
Oct 23, 2002·Journal of Neurochemistry·Elena B Rodriguez de TurcoMyron D Ginsberg
Feb 10, 2006·The New England Journal of Medicine·Gregory J del Zoppo
Feb 10, 2006·The New England Journal of Medicine·Kennedy R LeesUNKNOWN Stroke-Acute Ischemic NXY Treatment (SAINT I) Trial Investigators

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Citations

May 7, 2011·Stroke; a Journal of Cerebral Circulation·Michael D HillUNKNOWN Neurological Emergencies Treatment Trials Network
Mar 1, 2012·Clinical Trials : Journal of the Society for Clinical Trials·Stacie T GrinnonSelma Kunitz
Apr 18, 2012·Journal of Neuroinflammation·Hantamalala Ralay RanaivoMark S Wainwright
Jul 1, 2015·Clinical Chemistry and Laboratory Medicine : CCLM·Konstantinos MakrisMoyssis Lelekis
Dec 3, 2009·Critical Care Nursing Clinics of North America·Anne W Wojner Alexandrov
Mar 27, 2015·International Journal of Stroke : Official Journal of the International Stroke Society·Myron D Ginsberg, Michael D Hill
Dec 3, 2013·Progress in Neurobiology·Jialing LiuGuo-Yuan Yang
Aug 28, 2014·The Cochrane Database of Systematic Reviews·Timothy S Chang, Matthew B Jensen
Jul 28, 2016·Stroke; a Journal of Cerebral Circulation·Renee' H MartinUNKNOWN ALIAS Parts 1 and 2 and NETT Investigators
Jul 24, 2015·Genome Biology·Diana Le DucTorsten Schöneberg
Aug 28, 2013·Nature Reviews. Neurology·Waldo R Guerrero, Sean I Savitz
Jul 30, 2014·The Cochrane Database of Systematic Reviews·Joanna M WardlawGregory J del Zoppo
Sep 16, 2016·Neurocritical Care·Joseph B MillerRobert Welch

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Methods Mentioned

BETA
dissection
X-ray
CLASS
Chip

Software Mentioned

SAS®

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