title: Recombinant factor VIIa: unregulated continuous use in patients with bleeding and coagulopathy does not alter mortality and outcome.
abstract: Recombinant factor VIIa (rFVIIa) is used in patients with hemophilia who had developed inhibitors. A hemostatic effect has been demonstrated following the administration of rFVIIa in patients after trauma and bleeding. Currently, there is no widely accepted guideline for off-label rFVIIa usage in bleeding patients. We planned to review the rFVIIa utilization practice in our institution and develop policies and guidelines for future rFVIIa use. We acquired the medical records of 55 patients who received rFVIIa at our institution during 2003-2004. Patient charts were reviewed regarding their rFVIIa administration and indications, dose and frequency, cost, pre-rFVIIa blood component usage, utilization of hematology services and outcome were analyzed. Underlying liver disease with coagulopathy was the commonest (47%) indication for rFVIIa use. Recombinant FVIIa was successful (69%) in correcting laboratory parameters of coagulopathy, but did not alter outcome. Twenty-six of the 55 patients (47%) died during the same admission from their underlying diseases. Apart from two trauma patients, no one died from bleeding. We conclude that unregulated continuous administration of rFVIIa in bleeding/coagulopathic patients did not alter outcome. Closer monitoring of rFVIIa usage, including hematology consultation and enforcement of pre-rFVIIa blood component usage would optimize cost-effectiveness.
authors.affiliation: Department of Medicine, University of Kansas Medical Center and Hospital, Kansas City, KS 66160, USA. sganguly@kumc.edu
authors.forename: S
authors.initials: S
authors.lastname: Ganguly
authors.forename: K
authors.initials: K
authors.lastname: Spengel
authors.forename: L L
authors.initials: LL
authors.lastname: Tilzer
authors.forename: B
authors.initials: B
authors.lastname: O'neal
authors.forename: S Q
authors.initials: SQ
authors.lastname: Simpson
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001778:Blood Coagulation Disorders / Q000401:mortality / Q000628:therapy*; D016913:Blood Component Transfusion / Q000009:adverse effects; D004334:Drug Administration Schedule; D005167:Factor VII / Q000008:administration & dosage* / Q000009:adverse effects; D015942:Factor VIIa; D005260:Female; D006467:Hemophilia A / Q000150:complications / Q000188:drug therapy; D006470:Hemorrhage / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D011994:Recombinant Proteins; D005167:Factor VII; C103587:recombinant FVIIa; D015942:Factor VIIa