Experience with KOGENATE Bayer in surgical procedures.
The study objectives were to assess the efficacy of KOGENATE Bayer (Kogenate FS) in achieving haemostasis during surgical procedures in patients with severe haemophilia A and to evaluate its safety when given in the doses needed for this purpose. Dosing for surgical procedures was in accordance with clinical practice in the management of haemophilia A patients during and after surgery. Efficacy was evaluated by estimated blood loss and assessment of haemostasis as determined by the attending physician. Safety was assessed by the incidence of adverse events related to study drug and the incidence of viral seroconversions. In total, 15 previously treated patients (PTPs) and seven previously untreated patients (PUPs)/minimally treated patients (MTPs) underwent 30 surgical procedures ranging from minor (port placement/tooth extraction) to major (orthopaedic endoprosthesis/brain tumour excision) surgery. The efficacy profile was good to excellent as assessed by the attending physician, and recorded blood loss was minimal to none. No adverse events were recorded that were related to study drug. No viral seroconversions were observed. In conclusion, KOGENATE Bayer was shown to be safe and efficacious in patients with severe haemophilia A during surgical procedures.
Scharrer
I
I
Frankfurt University Hospital, Frankfurt, Germany. scharrer@em.uni-frankfurt.de
D000328:Adult; D016063:Blood Loss, Surgical / Q000517:prevention & control; D001803:Blood Transfusion / Q000706:statistics & numerical data; D002648:Child; D005169:Factor VIII / Q000627:therapeutic use*; D006467:Hemophilia A / Q000150:complications / Q000188:drug therapy*; D006488:Hemostasis, Surgical; D006801:Humans; D008875:Middle Aged; D013395:Sucrose; D013514:Surgical Procedures, Operative / Q000379:methods*
D013395:Sucrose; C078147:F8 protein, human; D005169:Factor VIII