drugset / Trial / NCT00235495
Albumin in Acute Ischemic Stroke Trial
Phase 3
Terminated
841 enrolled
University of Miami
Medical University of South Carolina · collabNational Institute of Neurological Disorders and Stroke (NINDS) · collabNeurological Emergencies Treatment Trials Network (NETT) · collabUniversity of Calgary · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The goal of the trial is to determine whether human albumin, administered within 5 hours of symptom onset, improves the 3-month outcome of subjects with acute ischemic stroke.
Timeline
- Start
- 2006-06
- Primary completion
- 2013-02
- Completion
- 2013-02
Publications
- Martin RH, Yeatts SD, Hill MD, Moy CS, Ginsberg MD, Palesch YY; ALIAS Parts 1 and 2 and NETT Investigators. ALIAS (Albumin in Acute Ischemic Stroke) Trials: Analysis of the Combined Data From Parts 1 and 2. Stroke. 2016 Sep;47(9):2355-9. doi: 10.1161/STROKEAHA.116.012825. Epub 2016 Jul 26.
- Hill MD, Martin RH, Palesch YY, Moy CS, Tamariz D, Ryckborst KJ, Jones EB, Weisman D, Pettigrew C, Ginsberg MD. Albumin Administration in Acute Ischemic Stroke: Safety Analysis of the ALIAS Part 2 Multicenter Trial. PLoS One. 2015 Sep 1;10(9):e0131390. doi: 10.1371/journal.pone.0131390. eCollection 2015.
- Ginsberg MD, Palesch YY, Hill MD, Martin RH, Moy CS, Barsan WG, Waldman BD, Tamariz D, Ryckborst KJ; ALIAS and Neurological Emergencies Treatment Trials (NETT) Investigators. High-dose albumin treatment for acute ischaemic stroke (ALIAS) Part 2: a randomised, double-blind, phase 3, placebo-controlled trial. Lancet Neurol. 2013 Nov;12(11):1049-58. doi: 10.1016/S1474-4422(13)70223-0. Epub 2013 Sep 27.
- Hill MD, Martin RH, Palesch YY, Tamariz D, Waldman BD, Ryckborst KJ, Moy CS, Barsan WG, Ginsberg MD; ALIAS Investigators; Neurological Emergencies Treatment Trials Network. The Albumin in Acute Stroke Part 1 Trial: an exploratory efficacy analysis. Stroke. 2011 Jun;42(6):1621-5. doi: 10.1161/STROKEAHA.110.610980. Epub 2011 May 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Albumin | Protein / enzyme biologic | 2 g/kg | Intravenous |