Evidence map›Paper›PMID 27462118›Full record

Trial reportStroke2016

ALIAS (Albumin in Acute Ischemic Stroke) Trials: Analysis of the Combined Data From Parts 1 and 2.

Renee' H Martin, Sharon D Yeatts, Michael D Hill, Claudia S Moy, Myron D Ginsberg, Yuko Y Palesch, ALIAS Parts 1 and 2 and NETT Investigators

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Stroke, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00235495 (A Phase III Randomized Multicenter Clinical Trial Of High-Dose Human Albumin Therapy For Neuroprotection In Acute Ischemic Stroke), which is not on this map. Cited by 53 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 5 pooled it
4.1field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00235495 phase3terminatednot on this map

A Phase III Randomized Multicenter Clinical Trial Of High-Dose Human Albumin Therapy For Neuroprotection In Acute Ischemic Stroke

TypeinterventionalSponsorUniversity of MiamiRan2006 to 2013Enrolled841ConditionsIschemic StrokeArmsAlbumin, Saline
3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 5 syntheses or guidelines pooled it, 86 citations in OpenAlex.

  1. Pooled it
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  5. Albumin therapy for acute ischemic stroke: a meta-analysis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2021
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Renee' H MartinFrom the Department of Public Health Sciences, Medical University of South Carolina, Charleston (R.H.M., S.D.Y., Y.Y.P.); Calgary Stroke Program, Department of Clinical Neurosciences, Medicine, Radiology and Community Health Sciences, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, AB, Canada (M.D.H.); Office of Clinical Research, National Institute of Neurological Disorders and Stroke, National Institutes of health, Bethesda, MD (C.S.M.); and Department of Neurology, University of Miami Miller School of Medicine, FL (M.D.G.). hebertrl@musc.edu.
Sharon D YeattsFrom the Department of Public Health Sciences, Medical University of South Carolina, Charleston (R.H.M., S.D.Y., Y.Y.P.); Calgary Stroke Program, Department of Clinical Neurosciences, Medicine, Radiology and Community Health Sciences, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, AB, Canada (M.D.H.); Office of Clinical Research, National Institute of Neurological Disorders and Stroke, National Institutes of health, Bethesda, MD (C.S.M.); and Department of Neurology, University of Miami Miller School of Medicine, FL (M.D.G.).
Michael D HillFrom the Department of Public Health Sciences, Medical University of South Carolina, Charleston (R.H.M., S.D.Y., Y.Y.P.); Calgary Stroke Program, Department of Clinical Neurosciences, Medicine, Radiology and Community Health Sciences, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, AB, Canada (M.D.H.); Office of Clinical Research, National Institute of Neurological Disorders and Stroke, National Institutes of health, Bethesda, MD (C.S.M.); and Department of Neurology, University of Miami Miller School of Medicine, FL (M.D.G.).
Claudia S MoyFrom the Department of Public Health Sciences, Medical University of South Carolina, Charleston (R.H.M., S.D.Y., Y.Y.P.); Calgary Stroke Program, Department of Clinical Neurosciences, Medicine, Radiology and Community Health Sciences, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, AB, Canada (M.D.H.); Office of Clinical Research, National Institute of Neurological Disorders and Stroke, National Institutes of health, Bethesda, MD (C.S.M.); and Department of Neurology, University of Miami Miller School of Medicine, FL (M.D.G.).
Myron D GinsbergFrom the Department of Public Health Sciences, Medical University of South Carolina, Charleston (R.H.M., S.D.Y., Y.Y.P.); Calgary Stroke Program, Department of Clinical Neurosciences, Medicine, Radiology and Community Health Sciences, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, AB, Canada (M.D.H.); Office of Clinical Research, National Institute of Neurological Disorders and Stroke, National Institutes of health, Bethesda, MD (C.S.M.); and Department of Neurology, University of Miami Miller School of Medicine, FL (M.D.G.).
Yuko Y PaleschFrom the Department of Public Health Sciences, Medical University of South Carolina, Charleston (R.H.M., S.D.Y., Y.Y.P.); Calgary Stroke Program, Department of Clinical Neurosciences, Medicine, Radiology and Community Health Sciences, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, AB, Canada (M.D.H.); Office of Clinical Research, National Institute of Neurological Disorders and Stroke, National Institutes of health, Bethesda, MD (C.S.M.); and Department of Neurology, University of Miami Miller School of Medicine, FL (M.D.G.).
ALIAS Parts 1 and 2 and NETT Investigators
Medical University of South Carolina · USNational Institute of Neurological Disorders and Stroke · US

Funding

Neurologic Emergencies Treatment Trials Network: Clinical Coordinating CenterU01NS056975 · NINDS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BARSAN, WILLIAM G · 2006 to 2015
$40.4M
ALIAS Phase lll Trial Albumin in Acute Ischemic StrokeU01NS040406 · NINDS · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI GINSBERG, MYRON DAVID · 2005 to 2011
$25.8M
The ALIAS StudyU01NS054630 · NINDS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI PALESCH, YUKO Y · 2005 to 2010
$6.9M
NINDS NIH HHS U01 NS040406NINDS NIH HHS U01 NS054630NINDS NIH HHS U01 NS056975
6 · The paper itself

Abstract

background and purposeThe ALIAS (Albumin in Acute Ischemic Stroke) part 1 and 2 trials evaluated whether 25% human serum albumin improves clinical outcomes after acute ischemic stroke above and beyond standard of care using similar protocols. The part 1 trial ended prematurely because of safety concerns, and the part 2 trial terminated early because of futility of finding a statistically significant effect of albumin over saline (control) administration. We combine the subject-level data of the part 1 and 2 trials to reevaluate the efficacy and safety outcomes with the larger sample size.

methodsThe combined data analyses closely follow those conducted in the part 2 trial. The primary outcome is the composite of the modified Rankin Scale and the National Institutes of Health Stroke Scale defined as a composite of modified Rankin Scale score 0 to 1 and National Institutes of Health Stroke Scale score 0 to 1 at 90 days from randomization. The unadjusted analyses use a simple Chi-square test, and those adjusting for baseline covariates use a generalized linear model with log link (to obtain relative risks).

resultsThe participant characteristics at baseline were generally similar between the treatment groups and between the trials; however, thrombolysis use was greater in part 2 (84% versus 75%), and the upper age limit imposed in part 2 resulted in a younger sample (mean age in part 1 was 69 versus 64 in part 2). In the combined sample, the proportions of good outcome in the 2 treatment groups were identical (41%). Similar results were observed in all secondary efficacy outcomes. Pulmonary edema was a consistent safety concern, with a 6-fold increase in the albumin arm (13%) compared with saline (2%; relative risk =7.76, 95% confidence interval 3.87-15.57).

conclusionsTreatment with intravenous albumin 25% at 2 g/kg was not associated with improved outcome at 90 days and was associated with increased rates of intracerebral hemorrhage and pulmonary edema. CLINICAL

trial registrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT00235495.

Indexed as

AlbuminsBrain IschemiaHumansStrokeTreatment OutcomeAlbuminsacute strokealbuminrandomized trialriskserum albumin

Identifiers

PMID27462118
PMCPMC4995121
OpenAlexW2487653617

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.