title: rFVIIa administered by continuous infusion during surgery in patients with severe congenital FVII deficiency.
abstract: The use of recombinant FVIIa (rFVIIa) to control bleed in individuals with FVII deficiency has been proven to be effective. The main problems associated with its use are that it requires frequent bolus injections to counteract its short half-life and high cost. Our study aimed to evaluate whether any advantage could be gained by providing rFVIIa by continuous infusion during surgery with regard to haemostatic efficacy, safety and cost. The prospective study included 10 patients with severe FVII deficiency, who underwent 25 surgical procedures (13 major and 12 minor procedures) and were treated with rFVIIa administered by continuous infusion. Tranexamic acid was given concomitantly every 8 h. Prothrombin time, FVII:C assay and thrombin generation assay were used to monitor the treatment. The mean total dose given was 10 mg during a major surgery and 4.4 mg during a minor surgery for a mean treatment duration of 7.5 and 4.0 days respectively. This corresponds to a reduction of 70-90% in drug usage and medication cost compared with bolus injections. Except for one major perioperative bleeding, excellent haemostasis was achieved in all procedures. One patient developed a transient inhibitory activity. None of these events affected the postoperative course or prolonged the hospital stay. Our study demonstrated that continuous infusion of rFVIIa during surgery is safe, effective and highly cost effective.
authors.affiliation: Research Institute of Internal Medicine Institute of Clinical Medicine, University of Oslo Department of Haematology Department of Orthopedics, Oslo University Hospital, Rikshospitalet, Oslo, Norway. hoa.thi.tuyet.tran@oslo-universitetssykehus.no
authors.forename: H T T
authors.initials: HT
authors.lastname: Tran
authors.forename: G E
authors.initials: GE
authors.lastname: Tjønnfjord
authors.forename: A
authors.initials: A
authors.lastname: Paus
authors.forename: P A
authors.initials: PA
authors.lastname: Holme
mesh_terms: D000293:Adolescent; D000328:Adult; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D005168:Factor VII Deficiency / Q000188:drug therapy*; D015942:Factor VIIa / Q000008:administration & dosage*; D005260:Female; D006488:Hemostasis, Surgical / Q000379:methods; D006490:Hemostatics / Q000008:administration & dosage*; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D019990:Perioperative Care; D011446:Prospective Studies; D011517:Prothrombin Time; D011994:Recombinant Proteins / Q000008:administration & dosage; D013917:Thrombin / Q000378:metabolism; D014148:Tranexamic Acid / Q000008:administration & dosage; D055815:Young Adult
chemical_list: D006490:Hemostatics; D011994:Recombinant Proteins; D014148:Tranexamic Acid; C103587:recombinant FVIIa; D015942:Factor VIIa; D013917:Thrombin