title: Safety and efficacy of high-purity concentrates in haemophiliac patients undergoing surgery by continuous infusion.
abstract: In this study we explore the feasibility of high-purity double-inactivated concentrates by continuous infusion for the treatment of haemophiliacs in a group of patients undergoing different surgical procedures. The patients were enrolled in the study on the basis of their transfusion history, which was well known due to their long-term follow up at our Haemophilia Center. We did not perform a pre-operative pharmacokinetic study because one of the aims of this study was to demonstrate that continuous infusion can become a first choice standard treatment in patients with haemophilia. Fourteen haemophilia A and one haemophilia B patients who needed at least 5 days of replacement therapy were monitored for haemostatic efficacy, post-operative factor VIII and factor IX levels and evaluated for safety and flexibility of the products. The infusion rate of 3 IU kg-1 h-1 was demonstrated to be sufficient to ensure haemostasis and patients did not need additional bolus infusion during the post-operative period. Our study demonstrates the safety and feasibility of high-purity concentrates in patients undergoing surgery by continuous infusion, also in the absence of a previous pharmacokinetic study.
authors.affiliation: Haemophilia Centre and Blood Bank, Centre for Blood Diseases, Castelfranco Veneto Hospital (TV), ULSS 8, Regione Veneto, Italy. tagariello@ulssasolo.ven.it
authors.forename: G
authors.initials: G
authors.lastname: Tagariello
authors.forename: P G
authors.initials: PG
authors.lastname: Davoli
authors.forename: G B
authors.initials: GB
authors.lastname: Gajo
authors.forename: E
authors.initials: E
authors.lastname: De Biasi
authors.forename: R
authors.initials: R
authors.lastname: Risato
authors.forename: R
authors.initials: R
authors.lastname: Baggio
authors.forename: A
authors.initials: A
authors.lastname: Traldi
mesh_terms: D000328:Adult; D005164:Factor IX / Q000032:analysis / Q000493:pharmacokinetics; D005169:Factor VIII / Q000008:administration & dosage* / Q000032:analysis / Q000493:pharmacokinetics*; D006467:Hemophilia A / Q000188:drug therapy* / Q000601:surgery*; D002836:Hemophilia B / Q000188:drug therapy / Q000601:surgery; D006801:Humans; D008875:Middle Aged; D019990:Perioperative Care; D010689:Phlebitis / Q000209:etiology; D013514:Surgical Procedures, Operative / Q000592:standards
chemical_list: D005169:Factor VIII; D005164:Factor IX