A safety study of Albumex 5, a human albumin solution produced by ion exchange chromatography.

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.

RCT Entities:   Population Interventions Outcomes