Efficacy and safety of a high purity, double virus inactivated factor VIII/von Willebrand factor concentrate (Biostate?) in patients with von Willebrand disorder requiring invasive or surgical procedures

Jake Shortt, Scott M Dunkley, Kevin A Rickard, Ross I Baker, Alison M Street

Research output: Contribution to journalArticleResearchpeer-review

19 Citations (Scopus)

Abstract

Biostate? is a double virally inactivated, plasma derived coagulation factor VIII (FVIII)/von Willebrand factor (VWF) concentrate registered and used in Australia, New Zealand and Asia for the treatment of patients with haemophilia A. Although Biostate? has been well characterized for FVIII and VWF (ratio 1:2 respectively) and shows a similar VWF multimeric pattern to normal plasma, limited published data is available on its clinical efficacy and safety in patients with von Willebrand disorder (VWD) who require surgical procedures. We retrospectively assessed the efficacy and safety of Biostate? in all VWD patients treated at three Australian haemophilia treatment centres undergoing invasive procedures or surgery over a 29-month period between April 2003 and September 2005. A chart review of 43 VWD patients (26 VWD type 1, 12 VWD type 2, 5 VWD type 3; 21 male, 22 female; mean age 52 years, range 19-80 years) undergoing 58 surgical procedures (24 major, 34 minor) was performed. For each procedure, data were collected on Biostate? dosage and administration, adverse reactions, haemostatic efficacy and bleeding events. Haemostatic efficacy of Biostate? was assessed as excellent in 78 or good in 22 of procedures. There were no bleeding events attributable to lack of efficacy in any patients. No adverse reactions related to the administration of Biostate? were observed. These results suggest that Biostate? is both safe and efficacious for the prevention of excessive bleeding in VWD patients undergoing surgery or invasive procedures.
Original languageEnglish
Pages (from-to)144 - 148
Number of pages5
JournalHaemophilia
Volume13
Issue number2
DOIs
Publication statusPublished - 2007
Externally publishedYes

Cite this