title: Continuous infusion of B-domain deleted recombinant factor VIII (ReFacto) in patients with haemophilia A undergoing surgery: clinical experience.
abstract: This retrospective, open-label, non-comparative study evaluated continuous infusion of recombinant factor VIII (ReFacto), B-domain deleted recombinant FVIII (BDDrFVIII), in patients with haemophilia A undergoing surgery and requiring >5 consecutive days of treatment. Sixteen patients from eight centres underwent a total of 20 procedures. Haemostatic outcome was assessed as 'excellent' or 'good' in 75% of procedures, and target FVIII:C levels were maintained throughout the continuous infusion period. The reported volume of blood loss during surgery was also within the normal range for non-haemophilic patients for the type of surgery performed. Red blood cell transfusions were required to balance excessive blood loss during BDDrFVIII continuous infusion in eight (40%) procedures (seven patients), five with bleeding or requiring volume replacement and three to treat anaemia secondary to blood loss. Non-serious adverse events considered by investigators as possibly or probably related to BDDrFVIII continuous infusion were infrequent (n = 5) considering the duration of treatment (n =239 cumulative days of continuous infusion), and all of these were mild-to-moderate in severity. No thromboembolic complications were reported except for one case of thrombophlebitis occurring at the infusion site. Only two patients (four events) experienced serious adverse bleeding; BDDrFVIII was otherwise well-tolerated. These data show that continuous infusion of BDDrFVIII provides reliable haemostasis and is an effective and well-tolerated regimen for patients with haemophilia A undergoing surgery.
authors.affiliation: Centre Régional de Traitement des Hémophiles, Hôpital Cochin, Paris, France. natalie.stieltjes@cch.ap-hop-paris.fr
authors.forename: N
authors.initials: N
authors.lastname: Stieltjes
authors.forename: C
authors.initials: C
authors.lastname: Altisent
authors.forename: G
authors.initials: G
authors.lastname: Auerswald
authors.forename: C
authors.initials: C
authors.lastname: Négrier
authors.forename: P
authors.initials: P
authors.lastname: Pouzol
authors.forename: J
authors.initials: J
authors.lastname: Reynaud
authors.forename: V
authors.initials: V
authors.lastname: Roussel-Robert
authors.forename: G F
authors.initials: GF
authors.lastname: Savidge
authors.forename: A
authors.initials: A
authors.lastname: Villar
authors.forename: S
authors.initials: S
authors.lastname: Schulman
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D016063:Blood Loss, Surgical / Q000517:prevention & control; D002648:Child; D002675:Child, Preschool; D005169:Factor VIII / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006467:Hemophilia A / Q000188:drug therapy*; D006488:Hemostasis, Surgical; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: C427184:recombinant factor VIII SQ; D005169:Factor VIII