Albumin Administration in Acute Ischemic Stroke: Safety Analysis of the ALIAS Part 2 Multicenter Trial.
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.


BACKGROUND
ClincalTrials.gov NCT00235495.
Departments of Clinical Neurosciences, Medicine, Radiology and Community Health Sciences, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
Michael D
MD
Hill
Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, United States of America.
Renee H
RH
Martin
Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, United States of America.
Yuko Y
YY
Palesch
Office of Clinical Research, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland, United States of America.
Claudia S
CS
Moy
Department of Neurology, University of Miami Miller School of Medicine, Miami, Florida, United States of America.
Diego
D
Tamariz
Department of Clinical Neurosciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
Karla J
KJ
Ryckborst
Department of Emergency Medicine, University of Texas Health Science Center at Houston, Houston, Texas, United States of America.
Elizabeth B
EB
Jones
Abington Neurological Associates, Abington, Pennsylvania, United States of America.
David
D
Weisman
Department of Neurology and Sanders-Brown Center on Aging, University of Kentucky, Lexington, Kentuck, United States of America.
Creed
C
Pettigrew
Department of Neurology, University of Miami Miller School of Medicine, Miami, Florida, United States of America.
Myron D
MD
Ginsberg
D054058:Acute Coronary Syndrome / Q000139:chemically induced; D000368:Aged; D000418:Albumins / Q000009:adverse effects / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000139:chemically induced; D002545:Brain Ischemia / Q000188:drug therapy*; D005260:Female; D006333:Heart Failure / Q000139:chemically induced; D006801:Humans; D008297:Male; D018696:Neuroprotective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D011654:Pulmonary Edema / Q000139:chemically induced; D011655:Pulmonary Embolism / Q000139:chemically induced; D020521:Stroke / Q000188:drug therapy*
D000418:Albumins; D018696:Neuroprotective Agents