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Coagulation factor IX: successful surgical experience with a purified factor IX concentrate.
J C Goldsmith1, C K Kasper, P M Blatt
1University of Nebraska Medical Center, Omaha.
American Journal of Hematology
|July 1, 1992
Summary
A purified coagulation factor IX concentrate, AlphaNine, shows safe and effective use in hemophilia B patients, including those undergoing surgery. This concentrate offers good recovery and half-life, minimizing risks associated with older treatments.
Area of Science:
- Hematology
- Pharmacokinetics
- Clinical Research
Background:
- Plasma-derived coagulation factor concentrates carry risks like viral transmission and thrombosis.
- Factor IX complex concentrates are associated with thrombosis, especially in neonates, liver disease patients, and surgical candidates.
Observation:
- Twenty patients received purified coagulation factor IX (Human) concentrate (AlphaNine) for pharmacokinetic studies.
- A two-compartment model revealed an initial phase half-life of 4.06 ± 2.86 hr and a beta phase half-life of 20.0 ± 3.8 hr.
- In vivo recovery was 62.7% ± 13.8%, with post-infusion factor IX levels averaging 73% ± 16% at 15 minutes.
Findings:
- Thirteen hemophilia B patients underwent major surgery (orthopedic, general, dental) using the purified factor IX concentrate.
- All patients achieved excellent surgical outcomes with no excessive bleeding.
- No laboratory or clinical evidence of disseminated intravascular coagulopathy was observed.
Implications:
- Purified coagulation factor IX concentrate (AlphaNine) demonstrates utility and safety in surgical patients with hemophilia B.
- This purified concentrate mitigates risks associated with older factor IX preparations.
- The study supports the use of AlphaNine in managing hemophilia B, even in complex patient groups.