The Albumin in Acute Stroke Trial (ALIAS); Design and methodology

International Journal of Stroke

Volumn 2, Issue 3, 2007, Pages 214-219

  Hill, Michael D ^a   Moy, Claudia S ^b   Palesch, Yuko Y ^c   Martin, Renee ^c   Dillon, Catherine R ^c   Waldman, Bonnie Darcy ^c   Patterson, Lynn ^c   Mendez, Isabel M ^d   Ryckborst, Karla J ^a   Tamariz, Diego ^d   Ginsberg, Myron D ^d  

^a UNIVERSITY OF CALGARY   (Canada)

^b NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE   (United States)

^c MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^d UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

Author keywords

Albumin; Ischaemic stroke; Randomised clinical trials

Indexed keywords

HUMAN ALBUMIN; PLACEBO; SODIUM CHLORIDE; TISSUE PLASMINOGEN ACTIVATOR;

ACUTE DISEASE; ADULT; ARTICLE; CEREBROVASCULAR ACCIDENT; CLINICAL TRIAL; COHORT ANALYSIS; CONGESTIVE HEART FAILURE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; FEASIBILITY STUDY; FIBRINOLYTIC THERAPY; HUMAN; LUNG EDEMA; MAJOR CLINICAL STUDY; METHODOLOGY; MULTICENTER STUDY; PHASE 3 CLINICAL TRIAL; PILOT STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RANKIN SCALE; SYMPTOM; TREATMENT OUTCOME;

ALBUMINS; DOUBLE-BLIND METHOD; FIBRINOLYTIC AGENTS; HUMANS; RESEARCH DESIGN; STROKE; TISSUE PLASMINOGEN ACTIVATOR;

EID: 34547114027     PISSN: 17474930     EISSN: 17474949     Source Type: Journal    
DOI: 10.1111/j.1747-4949.2007.00143.x     Document Type: Article

References (19)

1. Belayev L, Busto R, Zhao W, Clemens JA, Ginsberg MD: Effect of delayed albumin hemodilution on infarction volume and brain edema after transient middle cerebral artery occlusion in rats. J Neurosurg 1997; 87: 595-601.
2. Belayev L, Zhao W, Pattany PM et al. Diffusion-weighted magnetic resonance imaging confirms marked neuroprotective efficacy of albumin therapy in focal cerebral ischemia. Stroke 1998; 29: 2587-2599.
3. Belayev L, Liu Y, Zhao W, Busto R, Ginsberg MD: Human albumin therapy of acute ischemic stroke: Marked neuroprotective efficacy at moderate doses and with a broad therapeutic window. Stroke 2001; 32: 553-560.
4. Liu Y, Belayev L, Zhao W, Busto R, Belayev A, Ginsberg MD: Neuroprotective effect of treatment with human albumin in permanent focal cerebral ischemia: Histopathology and cortical perfusion studies. Eur J Pharmacol 2001; 428: 193-201.
5. Belayev L, Saul I, Huh PW, Finotti N, Zhao W, Busto R, Ginsberg MD: Neuroprotective effect of high-dose albumin therapy against global ischemic brain injury in rats. Brain Res 1999; 845: 107-111.
6. Belayev L, Alonso OF, Huh PW, Zhao W, Busto R, Ginsberg MD: Post-treatment with high-dose albumin reduces histopathological damage and improves neurological deficit following fluid percussion brain injury in rats. J Neurotrauma 1999; 16: 445-453.
7. Ginsberg M, Belayev L, Bazan N et al. Albumin-based neurotherapeutics for acute ischemic stroke: From bench to bedside; in Krieglstein J, Klumpp S (eds): Pharmacology of Cerebral Ischemia. Stuttgart: Medpharm Scientific Publishers, 2004: 421-433.
8. Huh PW, Belayev L, Zhao W, Busto R, Saul I, Ginsberg MD: The effect of high-dose albumin therapy on local cerebral perfusion after transient focal cerebral ischemia in rats. Brain Res 1998; 804: 105-113.
9. Belayev L, Pinard E, Nallet H et al. Albumin therapy of transient focal cerebral ischemia: In vivo analysis of dynamic microvascular responses. Stroke 2002; 33: 1077-1084.
10. Rodriguez de Turco EB, Belayev L, Liu Y, Busto R, Parkins N, Bazan NG, Ginsberg MD: Systemic fatty acid responses to transient focal cerebral ischemia: Influence of neuroprotectant therapy with human albumin. J Neurochem 2002; 83: 515-524.
11. Ginsberg MD, Palesch YY, Hill MD: The ALIAS (ALbumin In Acute Stroke) Phase III randomized multicentre clinical trial: Design and progress report. Biochem Soc Trans 2006; 34: 1323-1326.
12. Palesch YY, Hill MD, Ryckborst KJ, Tamariz D, Ginsberg MD: The ALIAS Pilot Trial: A dose-escalation and safety study of albumin therapy for acute ischemic stroke -II neurologic outcome and efficacy analysis. Stroke 2006; 37: 2107-2114.
13. Ginsberg MD, Hill MD, Palesch YY, Ryckborst KJ, Tamariz D: The ALIAS Pilot Trial: A dose-escalation and safety study of albumin therapy for acute ischemic stroke -I Physiological responses and safety results. Stroke 2006; 37: 2100-2106.
14. Wahlgren NG, Ranasinha KW, Rosolacci T, Franke CL, van Erven PM, Ashwood T, Claesson L: Clomethiazole acute sRroke study (class): results of a randomized, controlled trial of clomethiazole versus placebo in 1360 acute stroke patients. Stroke 1999; 30: 21-28.
15. Lyden P, Shuaib A, Ng K et al. Clomethiazole acute stroke study in ischemic stroke (class-i): Final results. Stroke 2002; 33: 122-128.
16. Lees KR, Zivin JA, Ashwood T et al. Nxy-059 for acute ischemic stroke. N Engl J Med 2006; 354: 588-600.
17. del Zoppo GJ.: Stroke and neurovascular protection. N Engl J Med 2006; 354: 553-555.
18. O'Brien PC, Fleming TR: A multiple testing procedure for clinical trials. Biometrics 1979; 35: 549-556.
19. Friedman LM, Furberg CD, DeMets DL: Fundamentals of Clinical Trials, 3rd edn. New York: Springer, 1996: 107-109.