title: Efficacy of a high purity, chemically treated and nanofiltered factor IX concentrate for continuous infusion in haemophilia patients undergoing surgery.
abstract: 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.
authors.affiliation: Coagulation Unit, Department of Haematology, Karolinska Hospital, Stockholm, Sweden. ssc@divmed.ks.se
authors.forename: S
authors.initials: S
authors.lastname: Schulman
authors.forename: R
authors.initials: R
authors.lastname: Wallensten
authors.forename: B
authors.initials: B
authors.lastname: White
authors.forename: O P
authors.initials: OP
authors.lastname: Smith
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004334:Drug Administration Schedule; D005164:Factor IX / Q000737:chemistry / Q000302:isolation & purification / Q000493:pharmacokinetics / Q000627:therapeutic use*; D005374:Filtration; D006207:Half-Life; D002836:Hemophilia B / Q000188:drug therapy* / Q000601:surgery; D006801:Humans; D007262:Infusions, Intravenous; D008657:Metabolic Clearance Rate; D008832:Microchemistry; D008875:Middle Aged; D009985:Orthopedics; D011183:Postoperative Complications
chemical_list: D005164:Factor IX