Surgical evaluation of a recombinant factor VIII prepared using a plasma/albumin-free method: Efficacy and safety of Advate in previously treated patients

Claude Négrier; Amy Shapiro; Erik Berntorp; Ingrid Pabinger; Michael Tarantino; Antonio Retzios; Phillip Schroth; Bruce Ewenstein

doi:10.1160/TH08-02-0117

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 2008; 100(02): 217-223
DOI: 10.1160/TH08-02-0117

Blood Coagulation, Fibrinolysis and Cellular Haemostasis

Schattauer GmbH

Surgical evaluation of a recombinant factor VIII prepared using a plasma/albumin-free method: Efficacy and safety of Advate in previously treated patients

Authors

Claude Négrier

¹Hôpital Edouard Herriot, Lyon, France
Amy Shapiro

²Indiana Hemophilia and Thrombosis Center, Indianapolis, Indiana, USA
Erik Berntorp

³University Hospital MAS, Malmö, Sweden
Ingrid Pabinger

⁴Allgemeines Krankenhaus der Stadt Wien, Vienna, Austria
Michael Tarantino

⁵Comprehensive Bleeding Disorders Center, Peoria, Illinois, USA
Antonio Retzios

⁶Baxter Healthcare Corporation, Westlake Village, California, USA
Phillip Schroth

⁶Baxter Healthcare Corporation, Westlake Village, California, USA
Bruce Ewenstein

⁶Baxter Healthcare Corporation, Westlake Village, California, USA

Abstract

Summary

Evaluation of factor F(V)III replacement in patients with haemophilia A undergoing surgery is critical for FVIII concentrates, yet large scale, multi-center prospective studies, particularly using continuous infusion, are generally lacking for new products. This study evaluated efficacy and safety of a newly developed recombinant FVIII (rAHF-PFM) administered by bolus or continuous infusion in haemophilia A patients undergoing surgery. Subjects ≥5 years of age with baseline FVIII:C ≤2%, and ≥150 prior FVIII exposure days were included in this prospective, international, open-label, uncontrolled clinical trial. rAHFPFM was administered perioperatively by bolus infusion (BI) or continuous infusion (CI) according to the standard use at the center to prevent bleeding complication. Both the surgeon and haematologist rated efficacy during hospitalization. Fifty-eight subjects underwent 65 surgical procedures (22 major haemor rhagic risk; 35 minor, 8 dental procedures). Bolus infusion was used exclusively in 47 procedures and continuous infusion, with or without supplemental bolus infusions, in 18.Haemostatic efficacy was assessed as excellent or good for 100% of intraoperative ratings (17 CI, 44 BI, 61 total procedures), and 100% of postoperative ratings performed at time of discharge (18 CI, 44 BI, 62 total procedures). Median total consumption of rAHF-PFM during hospitalization was 822 IU/kg/surgery with CI and 910 IU/kg/surgery with BI. Overall rAHF-PFM was well tolerated, and FVIII inhibitors were not detected. In conclusion, rAHF-PFM administered via continuous infusion or bolus injections is safe, non-immunogenic, and effective for perioperative hemostatic management in previously treated haemophilia A patients.

Keywords

Haemophilia A - factor VIII - rAHF-PFM - rFVIII - surgery - continuous infusion

Full Text

References

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