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Reconstituted recombinant factor VIII can be safely infused continuously for at least three days: it is a poor
M E Didier1, S Fischer, D G Maki
1Department of Medicine, University of Wisconsin Medical School, Madison, USA.
Abstract:
Reconstituted recombinant factor VIII (FVIIIrec) loses little biologic activity at room temperature for up to seven days and continuous infusion is convenient, effective hemostatically and requires less FVIIIrec concentrate than treatment by conventional bolus injections. However, the potential for bacterial contamination, with proliferation to high levels that can cause bacteremia, is a concern with continuous infusion. We studied the growth properties at 4, 25 and 35 degrees C in reconstituted FVIIIrec (Kogenate) and at 25 degrees C in 5% dextrose in water (D5%W) of three isolates each of Staphylococcus epidermidis, Staphylococcus aureus, Enterobacter cloacae, Klebsiella oxytoca, Serratia marcescens, Acinetobacter calcoaceticus, Stenotrophomonas maltophilia, Pseudomonas aeruginosa, Burkholderia cepacia, Flavobacterium spp. and Candida albicans, species most likely to contaminate infusate during preparation or administration and which have been implicated in more than 95% of all outbreaks and sporadic cases of nosocomial bloodstream infection traced to contaminated admixtures, biologic agents or medications administered parenterally. Reconstituted FVIIIrec allowed growth of only three species at 25 degrees C and 35 degrees C: S. marcescens, S. maltophilia and P. aeruginosa; logarithmic growth appeared only after 24-48 h. D5%W allowed growth of two gram-negative species, S. marcescens and B. cepacia. We conclude that reconstituted FVIIIrec (Kogenate) is a poor growth medium for most nosocomial pathogens, comparable with D5%W. If reconstituted aseptically, continuous infusion of reconstituted FVIIIrec should be safe, and it should not be necessary to replace the container or tubing more frequently than every 3 days, an administration schedule that can provide effective hemostasis at lower cost.
Insights
Reconstituted recombinant factor VIII (FVIIIrec) is a poor growth medium for most pathogens. Aseptic preparation allows safe continuous infusion, reducing costs and improving hemostasis.
Area of Science:
- Microbiology
- Hematology
- Pharmaceutical Science
Background:
- Recombinant factor VIII (FVIIIrec) offers convenient and effective hemostasis via continuous infusion, but bacterial contamination is a concern.
- Nosocomial bloodstream infections are often linked to contaminated parenteral medications and admixtures.
Purpose of the Study:
- To evaluate the growth potential of common nosocomial pathogens in reconstituted FVIIIrec (Kogenate) under various temperature conditions.
- To compare the growth-supporting properties of FVIIIrec with 5% dextrose in water (D5%W).
Main Methods:
- Studied bacterial and fungal growth in reconstituted FVIIIrec and D5%W at 4, 25, and 35 degrees C.
- Inoculated with three isolates each of 11 common nosocomial pathogens, including Staphylococcus, Enterobacter, Serratia, Stenotrophomonas, Pseudomonas, Burkholderia, Flavobacterium, and Candida species.
Main Results:
- Reconstituted FVIIIrec supported logarithmic growth of only Serratia marcescens, Stenotrophomonas maltophilia, and Pseudomonas aeruginosa at 25 and 35 degrees C, with growth delayed by 24-48 hours.
- D5%W supported growth of S. marcescens and Burkholderia cepacia.
- Most tested pathogens did not exhibit significant growth in FVIIIrec at tested temperatures.
Conclusions:
- Reconstituted FVIIIrec is a poor growth medium for the majority of nosocomial pathogens, similar to D5%W.
- Aseptic preparation of FVIIIrec enables safe continuous infusion, potentially allowing for less frequent tubing replacement (every 3 days).
- This administration schedule can provide effective hemostasis at a reduced cost.