RECONSTITUTED RECOMBINANT FACTOR-VIII CAN BE SAFELY INFUSED CONTINUOUSLY FOR AT LEAST 3 DAYS - IT IS A POOR MICROBIAL-GROWTH MEDIUM

Reconstituted recombinant factor VIII (FVIIIrec) loses little biologic activity at room temperature for up to seven days and continuous infu sion is convenient, effective hemostatically and requires less FVIIIre c concentrate than treatment by conventional bolus injections. However , the potential for bacterial contamination, with proliferation to hig h levels that can cause bacteremia, is a concern with continuous infus ion. We studied the growth properties at 4, 25 and 35 degrees C in rec onstituted FVIIIrec (Kogenate(R)) and at 25 degrees C in 5% dextrose i n water (D5%W) of three isolates each of Staphylococcus epidermidis, S taphylococcus aureus, Enterobacter cloacae, Klebsiella oxytoca, Serrat ia marcescens, Acinetobacter calcoaceticus, Stenotrophomonas maltophil ia, Pseudomonas aeruginosa, Burkholderia cepacia, Flavobacterium spp. and Candida albicans, species most likely to contaminate infusate duri ng preparation or administration and which have been implicated in mor e than 95% of all outbreaks and sporadic cases of nosocomial bloodstre am infection traced to contaminated admixtures, biologic agents or med ications administered parenterally. Reconstituted FVIIIrec allowed gro wth of only three species at 25 degrees C and 35 degrees C: S. marcesc ens, S. maltophilia and P. aeuruginosa; logarithmic growth appeared on ly after 24-48 h. D5%W allowed growth of two gram-negative species, S. marcescens and B. cepacia. We conclude that reconstituted FVIIIrec (K ogenate(R)) is a poor growth medium for most nosocomial pathogens, com parable with D5%W. If reconstituted aseptically, continuous infusion o f reconstituted FVIIIrec should be safe, and it should not be necessar y to replace the container or tubing more frequently than every 3 days , an administration schedule that can provide effective hemostasis at lower cost. Blood Coag Fibrinol 9:227-232 (C) 1998 Lippincott-Raven Pu blishers.