Efficacy of a sucrose-formulated recombinant factor VIII used for 22 surgical procedures in patients with severe haemophilia A.
A sucrose-formulated recombinant FVIII (rFVIII-SF) was investigated under clinical trial conditions during surgical procedures in previously treated patients (PTPs). Fifteen PTPs with severe haemophilia A (FVIII < or = 1%) underwent 22 surgical procedures. The procedures performed cover a spectrum from minor to major surgery. Haemostatic outcome was assessed by the investigators to be excellent in 16 procedures and good in the remaining six procedures. It is concluded that rFVIII-SF is efficacious and safe in severe haemophilia A patients undergoing minor or major surgery.
Scharrer
I
I
Hemophilia Center, University of Frankfurt, Frankfurt, Germany. scharrer@em.uni-frankfurt.de
Brackmann
H H
HH
Sultan
Y
Y
Abshire
T
T
Gazengel
C
C
Ragni
M
M
Gorina
E
E
Vosburgh
E
E
Kellermann
E
E
D000208:Acute Disease; D000328:Adult; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D002626:Chemistry, Pharmaceutical; D005169:Factor VIII / Q000008:administration & dosage* / Q000737:chemistry; D005260:Female; D006467:Hemophilia A / Q000188:drug therapy* / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000737:chemistry; D013395:Sucrose; D016896:Treatment Outcome
D011994:Recombinant Proteins; D013395:Sucrose; C078147:F8 protein, human; D005169:Factor VIII