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.

TRIAL REGISTRATION: ClincalTrials.gov NCT00235495.

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Published in PLOS One, vol. 10, no. 9, article e0131390, p. 1-13.

This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication

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Funding Information

This work was 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).

S1_ALIAS_Enrolling_Site_Ethics_Board_List.xlsx (14 kB)
S1 ALIAS Enrolling Site Ethics Board List.

S1_CONSORT_Checklist.pdf (680 kB)
S1 CONSORT Checklist: CONSORT Trial checklist.

S1_Protocol.pdf (360 kB)
S1 Protocol: ALIAS Protocol.

S1_Table.docx (71 kB)
S1 Table: Adverse Events among patients with sICH vs. non-ICH patients.

S2_Table.docx (110 kB)
S2 Table: VISTA data population.