title: [Risk assessment of thrombotic events after the use of activated factor VII].
abstract: BACKGROUND
  The objective of this study was to analyze the incidence of thrombotic complications related to recombinant human factor viia (rFVIIa) therapy for severe postoperative bleeding in cardiac surgery.
  
  
  METHODS
  A retrospective matched case-control study was conducted over two years, including 72 children admitted to intensive care unit and treated with rFVIIa because of a severe bleeding during or after cardiac surgery. A control group of 63 patients was chosen, who were statistically comparable in sex, weight, diagnosis, surgical risk according RASCH-1 score, and surgical characteristics, was chosen.
  
  
  RESULTS
  There were no significant differences between cases and controls either in the rate of thrombosis (20% vs 28%, P=.540), or in the mortality rate (16% vs 9.5%, P=.208).
  
  
  CONCLUSIONS
  In our study, the rFVIIa therapy was shown to be useful in controlling severe operative bleeding in pediatric cardiac surgery, but does not seem to increase the risk of thrombotic complications or mortality rate in the postoperative period.
authors.affiliation: Servicio de Cuidados Intensivos Pediátricos, Hospital General Universitario Gregorio Marañón, Madrid, España. m.carmen.martinez11@gmail.com
authors.forename: M C
authors.initials: MC
authors.lastname: Martínez López
authors.forename: A J
authors.initials: AJ
authors.lastname: Alcaraz Romero
authors.forename: A B
authors.initials: AB
authors.lastname: Martínez López
authors.forename: C M
authors.initials: CM
authors.lastname: Fernández-Llamazares
authors.forename: C
authors.initials: C
authors.lastname: Ramos Navarro
mesh_terms: D006348:Cardiac Surgical Procedures; D016022:Case-Control Studies; D002675:Child, Preschool; D015942:Factor VIIa / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D019106:Postoperative Hemorrhage / Q000188:drug therapy; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012189:Retrospective Studies; D018570:Risk Assessment; D012720:Severity of Illness Index; D013927:Thrombosis / Q000139:chemically induced* / Q000453:epidemiology*
chemical_list: D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa