Albumin administration in acute ischemic stroke: Safety analysis of the ALIAS Part 2 Multicenter Trial

Michael D. Hill, Renee H. Martin, Yuko Y. Palesch, Claudia S. Moy, Diego Tamariz, Karla J. Ryckborst, Elizabeth B. Jones, David Weisman, Creed Pettigrew, Myron D. Ginsberg

Research output: Contribution to journalArticlepeer-review

9 Scopus citations


Background: Albumin treatment of ischemic stroke was associated with cardiopulmonary adverse events in previous studies and a low incidence of intracranial hemorrhage.We sought to describe the neurological and cardiopulmonary adverse events in the ALIAS Part 2 Multicenter Trial. Methods: Ischemic stroke patients, aged 18-83 and a baseline NIHSS ≥ 6, were randomized to treatment with ALB or saline control within 5 hours of stroke onset. Neurological adverse events included symptomatic intracranial hemorrhage, hemicraniectomy, neurological deterioration and neurological death. Cardiopulmonary adverse events included pulmonary edema/congestive heart failure, acute coronary syndromes, atrial fibrillation, pneumonia and pulmonary thromboembolism. Results: Among 830 patients, neurological and cardiopulmonary adverse events were not differentially associated with poor outcome between ALB and saline control subjects. The rate of symptomatic intracranial hemorrhage in the first 24h was low overall (2.9%, 24/830) but more common in the ALB treated subjects (RR = 2.4, CI95 1.01-5.8). The rate of pulmonary edema/CHF in the first 48h was 7.9% (59/830) and was more common among ALB treated subjects (RR = 10.7, CI95 4.3-26.6); this complication was expected and was satisfactorily managed with mandated diuretic administration and intravenous fluid guidelines. Troponin elevations in the first 48h were common, occurring without ECG change or cardiac symptoms in 52 subjects (12.5%). Conclusions: ALB therapy was associated with an increase in symptomatic ICH and pulmonary edema/congestive heart failure but this did not affect final outcomes. Troponin elevation occurs routinely in the first 48 hours after acute ischemic stroke.

Original languageEnglish
Article numbere0131390
JournalPLoS ONE
Issue number9
StatePublished - Sep 1 2015

Bibliographical note

Funding Information:
The trial was funded by the U.S. National Institutes of Health/National Institute of Neurological Disorders and Stroke. A representative of NINDS (CSM) participated in study design, management and interpretation. Baxter Healthcare Corporation provided funds to extend the trial to Finland but played no role in the design, execution, or interpretation of the study.

Funding Information:
Supported by cooperative agreements from the National Institute of Neurological Disorders and Stroke, National Institutes of Health (U01NS040406, University of Miami; U01NS054630, Medical University of South Carolina; U01NS056975, University of Michigan; U10NS058967, University of Kentucky).

ASJC Scopus subject areas

  • General


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