Related Experiment Videos
Stability of factor VIII concentrates after reconstitution
S Schulman1, S Gitel, U Martinowitz
1National Hemophilia Center, Chaim Sheba Medical Center, Tel Hashomer, Israel.
American Journal of Hematology
|March 1, 1994
Summary
Continuous infusion of factor VIII (F VIII) reduces surgical doses. Many F VIII concentrates show better stability than stated, supporting their use in extended infusions.
Area of Science:
- Hematology
- Biochemistry
- Pharmaceutical Science
Background:
- Continuous infusion of factor VIII (F VIII) offers dose reduction (50-75%) in surgical patients.
- Factor concentrate instability limits current continuous infusion protocols.
- Manufacturers recommend short infusion times post-reconstitution.
Purpose of the Study:
- To assess the stability of 15 lyophilized F VIII products.
- To determine optimal storage conditions and duration for F VIII concentrates.
- To evaluate the feasibility of using F VIII concentrates for continuous infusion.
Main Methods:
- Reconstituted F VIII samples stored at 4-8°C, 20-23°C, and 37°C for up to 4 weeks.
- Storage in original containers and plastic tubes, with subsequent freezing.
- F VIII activity measured using one-stage clotting and chromogenic assays.
Main Results:
- F VIII concentrate stability exceeded manufacturer claims.
- Some concentrates showed activation, more frequently at 4-8°C.
- Several products maintained >80% activity for 4 weeks at 4-8°C or 20-23°C.
Conclusions:
- Many F VIII concentrates exhibit sufficient stability for continuous infusion.
- Current stability data suggest broader applicability of continuous infusion protocols.
- Further research may refine guidelines for F VIII concentrate usage in prolonged infusions.