title: Use of recombinant factor VIIa for uncontrolled bleeding in neonates after cardiopulmonary bypass.
abstract: BACKGROUND
  Increasingly, recombinant activated factor VII (rFVIIa) is used adjunctively in nonhemophiliacs to control hemorrhage unresponsive to conventional therapy in a variety of settings including postcardiopulmonary bypass (CPB). Studies examining rFVIIa administration to neonates after CPB are limited. The goal of this study was to evaluate retrospectively the clinical outcomes of neonates treated at our institution with rFVIIa for uncontrolled post-CPB bleeding.
  
  
  METHODS
  We retrospectively identified eight neonates undergoing complex congenital cardiac surgery who received rFVIIa, either intraoperatively or postoperatively, for uncontrolled post-CPB bleeding. Transfusion trends and prothrombin times (PT) were assessed both pre- and post-rFVIIa administration. Chest tube drainage volumes were recorded pre- and post-rFVIIa administration in those neonates receiving rFVIIa postoperatively in the intensive care unit. We documented such adverse events as thrombosis, dialysis (hemodialysis and peritoneal dialysis), extracorporeal membrane oxygenation (ECMO) and in-hospital mortality.
  
  
  RESULTS
  The mean amount of transfused packed red blood cells, platelets and fresh frozen plasma decreased significantly after the administration of rFVIIa. Transfusion of cryoprecipitate trended towards a decrease but did not reach statistical significance. PT values also decreased significantly after the administration of rFVIIa. A high mortality was found in neonates exposed to both rFVIIa and ECMO; however, this was not significantly different from the mortality of neonates exposed to ECMO alone.
  
  
  CONCLUSIONS
  Administration of rFVIIa to neonates for the treatment of uncontrolled post-CPB bleeding significantly reduced transfusion requirements and normalized PT values. Future randomized, controlled trials are needed to evaluate the potential hemostatic benefit and adverse effects of rFVIIa administration to neonates following CPB.
authors.affiliation: Department of Anesthesiology, Emory University School of Medicine, Children's Healthcare of Atlanta at Egleston, Atlanta, GA 30322, USA. nina.guzzetta@emoryhealthcare.org
authors.forename: Nina A
authors.initials: NA
authors.lastname: Guzzetta
authors.forename: Shane
authors.initials: S
authors.lastname: Huch
authors.forename: Janet D
authors.initials: JD
authors.lastname: Fernandez
authors.forename: Steven R
authors.initials: SR
authors.lastname: Tosone
authors.forename: Bruce E
authors.initials: BE
authors.lastname: Miller
mesh_terms: D001803:Blood Transfusion; D002315:Cardiopulmonary Bypass; D015199:Extracorporeal Membrane Oxygenation; D015942:Factor VIIa / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D010530:Peritoneal Dialysis; D010976:Platelet Count; D011183:Postoperative Complications / Q000453:epidemiology; D019106:Postoperative Hemorrhage / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality; D011517:Prothrombin Time; D011994:Recombinant Proteins / Q000627:therapeutic use; D006435:Renal Dialysis; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa