title: Recombinant activated factor VII in cardiac surgery: single-center experience.
abstract: BACKGROUND
  The widespread off-label use of recombinant activated factor VII for the control of refractory postoperative hemorrhage continues despite a warning from the Food and Drug Administration. Although effective in reducing the need for transfusion of blood and blood products, safety concerns still prevail.
  
  
  OBJECTIVE
  To compare the dosing and efficacy of recombinant activated factor VII between pediatric and adult patients, and in the operating room and intensive care unit.
  
  
  METHODS
  The records of 69 patients (33 children and 36 adults) who underwent cardiovascular surgery and received recombinant activated factor VII were reviewed retrospectively. The dose of recombinant activated factor VII, mediastinal drainage, use of blood and blood products, incidence of thrombosis, and 28-day mortality were studied.
  
  
  RESULTS
  the efficacy of recombinant activated factor VII was comparable in adults and children, despite the lower dose in adults. Prophylactic use of recombinant activated factor VII decreased the incidence of mediastinal exploration and the duration of intensive care unit stay. A 4.3% incidence of thrombotic complications was observed in this study.
  
  
  CONCLUSIONS
  The efficacious dose of recombinant activated factor VII is much less in adults compared to children. Prophylactic use of recombinant activated factor VII decreases the dose required, the incidence of mediastinal exploration, and intensive care unit stay, with no survival benefit.
authors.affiliation: Department of Cardiac Anesthesia, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Sarvesh Pal
authors.initials: SP
authors.lastname: Singh
authors.forename: Sandeep
authors.initials: S
authors.lastname: Chauhan
authors.forename: Minati
authors.initials: M
authors.lastname: Choudhury
authors.forename: Vishwas
authors.initials: V
authors.lastname: Malik
authors.forename: Shiv Kumar
authors.initials: SK
authors.lastname: Choudhary
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D006348:Cardiac Surgical Procedures / Q000009:adverse effects* / Q000401:mortality; D002648:Child; D002675:Child, Preschool; D004334:Drug Administration Schedule; D054796:Drug Dosage Calculations; D015942:Factor VIIa / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006490:Hemostatics / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007194:India; D007362:Intensive Care Units; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D009873:Operating Rooms; D019106:Postoperative Hemorrhage / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D012086:Reoperation; D012189:Retrospective Studies; D013927:Thrombosis / Q000139:chemically induced / Q000628:therapy; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D006490:Hemostatics; D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa
keywords: Blood loss; Cardiac surgical procedures; Factor VIIa; Postoperative hemorrhage; Recombinant proteins; surgical