We have evaluated the haemostatic efficacy of plasma derived, highly purified,
solvent-
detergent treated
factor IX concentrate (Nanotiv), to which a nanofiltration step has recently been added to improve safety with regard to parvovirus B19,
hepatitis A and other nonlipid enveloped viruses. Thirteen
surgical procedures, including eight orthopaedic operations, were carried out using continuous infusion of Nanotiv in 10
haemophilia B patients (nine severe and one mild).
Tranexamic acid was used for 11 of the 13 procedures. The mean
factor IX levels on the day of surgery and postoperative days 1-3 were 0.77, 0.89, 0.80 and 0.73 IU mL(-1), respectively. The haemostatic effect was rated as normal or excellent and no
blood transfusions were needed. One patient had
thrombophlebitis twice at the infusion site. The remaining cases received
heparin, 5 units per 100 IU of Nanotiv, and had neither superficial nor deep venous thromboembolic complications. The requirement for
factor IX in the four
joint replacement operations was 663 IU kg(-1) during the first 9 days, which compares favourably with previous materials. Thus, continuous infusion with this highly purified
factor IX concentrate with improved viral safety is effective for surgery in
haemophilia B.