title: Prospective, randomised trial of two doses of rFVIIa (NovoSeven) in haemophilia patients with inhibitors undergoing surgery.
abstract: Recombinant factor VIIa (rFVIIa: NovoSeven; Novo Nordisk) has proven efficacy in the treatment of haemophilic patients with inhibitors. This prospective, double-blind study compared rFVIIa (35 vs. 90 microg/kg) in the initiation and maintenance of haemostasis during and after elective surgery. Patients with inhibitors (FVIII, n = 26; FIX, n = 3) received rFVIIa immediately prior to incision; intraoperatively as needed; every 2 h for the first 48 h; and every 2-6 h for the following 3 days. Haemostasis was evaluated during surgery, at 0, 8, 24 and 48 h and 3, 4 and 5 days after wound closure. After day 5, open-label rFVIIa (90 microg/kg) was available for maintenance. Intraoperative haemostasis was achieved in 28/29 patients. All high-dose patients and 12/15 low dose patients had satisfactory haemostasis during the first 48 h. Twenty-three patients (13/14 high dose) successfully completed the study. Although the 35 microg/kg dose is probably sub-optimal for post-operative management, at least in major procedures, rFVIIa 90 microg/kg is an effective first-line option in surgery for patients with inhibitors.
authors.affiliation: Indiana University Medical Center, Hemophilia Center, Indianapolis 46260, USA.
authors.forename: A D
authors.initials: AD
authors.lastname: Shapiro
authors.forename: G S
authors.initials: GS
authors.lastname: Gilchrist
authors.forename: W K
authors.initials: WK
authors.lastname: Hoots
authors.forename: H A
authors.initials: HA
authors.lastname: Cooper
authors.forename: D A
authors.initials: DA
authors.lastname: Gastineau
mesh_terms: D000293:Adolescent; D000328:Adult; D001323:Autoantibodies / Q000276:immunology*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D017558:Elective Surgical Procedures; D005164:Factor IX / Q000276:immunology*; D005169:Factor VIII / Q000276:immunology*; D015942:Factor VIIa / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006467:Hemophilia A / Q000150:complications / Q000276:immunology / Q000628:therapy*; D002836:Hemophilia B / Q000150:complications / Q000276:immunology / Q000628:therapy*; D006470:Hemorrhage / Q000517:prevention & control; D006488:Hemostasis, Surgical / Q000379:methods*; D006801:Humans; D007223:Infant; D007518:Isoantibodies / Q000276:immunology*; D008297:Male; D011446:Prospective Studies; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D001323:Autoantibodies; D007518:Isoantibodies; D011993:Recombinant Fusion Proteins; D005169:Factor VIII; D005164:Factor IX; D015942:Factor VIIa