title: A safety study of Albumex 5, a human albumin solution produced by ion exchange chromatography.
abstract: Human serum albumin solutions have been used as plasma replacement fluids for many years and adverse events associated with their use are rare. Albumex 5 is a new albumin solution manufactured by a combination of the Cohn fractionation process and a chromatographic technique. A multicentre, randomised study was conducted to compare the safety of Albumex 5 and 5% normal serum albumin (5% NSA) in patients undergoing large volume therapeutic plasmapheresis for a variety of disorders. Up to six exchanges were performed on each patient. A total of 208 evaluable exchanges were performed on 40 patients, 109 5% NSA and 99 Albumex 5. There were 9 adverse events (reaction rate of 8.3%) in 6 patients with 5% NSA and 12 events (reaction rate 12.1%) in 8 patients with Albumex 5. The difference is not statistically significant (p = 0.37, Fisher's exact test). None of the adverse events were considered serious. Only six reactions were thought to be possibly related to the product and three exchanges were modified as a result of an adverse event; one with Albumex 5 was interrupted and two with 5% NSA were slowed. Albumex 5 can be considered to be a safe product with a low adverse event rate.
authors.affiliation: Division of Haematology and Medical Oncology, Peter MacCallum Cancer Institute, East Melbourne, Vic, Australia.
authors.forename: M
authors.initials: M
authors.lastname: Wolf
authors.forename: H
authors.initials: H
authors.lastname: Kronenberg
authors.forename: A
authors.initials: A
authors.lastname: Dodds
authors.forename: P
authors.initials: P
authors.lastname: Miach
authors.forename: J
authors.initials: J
authors.lastname: Isbister
authors.forename: M
authors.initials: M
authors.lastname: Levidiotis
authors.forename: K
authors.initials: K
authors.lastname: Dear
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002852:Chromatography, Ion Exchange; D003080:Cold Temperature; D000431:Ethanol; D005260:Female; D005374:Filtration; D005440:Fluid Therapy; D006358:Hot Temperature; D006801:Humans; D007022:Hypotension / Q000139:chemically induced; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D010951:Plasma Exchange / Q000009:adverse effects; D012449:Safety; D012709:Serum Albumin / Q000008:administration & dosage / Q000009:adverse effects* / Q000302:isolation & purification; D013242:Sterilization / Q000379:methods
chemical_list: D012709:Serum Albumin; D000431:Ethanol