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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.
AuthorsS Schulman, R Wallensten, B White, O P Smith
JournalHaemophilia : the official journal of the World Federation of Hemophilia (Haemophilia) Vol. 5 Issue 2 Pg. 96-100 (Mar 1999) ISSN: 1351-8216 [Print] ENGLAND
PMID10215956 (Publication Type: Journal Article)
Chemical References
  • Factor IX
Topics
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Drug Administration Schedule
  • Factor IX (chemistry, isolation & purification, pharmacokinetics, therapeutic use)
  • Filtration
  • Half-Life
  • Hemophilia B (drug therapy, surgery)
  • Humans
  • Infusions, Intravenous
  • Metabolic Clearance Rate
  • Microchemistry
  • Middle Aged
  • Orthopedics
  • Postoperative Complications

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