title: Recombinant activated factor VII for refractory bleeding after acute aortic dissection surgery: a propensity score analysis.
abstract: OBJECTIVE
  The aim of this study was to assess safety and effectiveness of recombinant activated factor VII (rFVIIa) in patients with refractory bleeding undergoing acute aortic dissection surgery with deep hypothermic circulatory arrest.
  
  
  METHODS
  Propensity score-matched analysis.
  
  
  METHODS
  University hospital.
  
  
  METHODS
  Twenty-three cardiac surgery patients receiving rFVIIa compared with 23 matched controls.
  
  
  METHODS
  An intravenous bolus of rFVIIa (70 microg/kg) was administered at the end of a complete transfusion protocol. Five patients received rFVIIa in the operating room, and 18 patients received rFVIIa in the intensive care unit. Four of the intensive care unit patients required a second dose.
  
  
  RESULTS
  Blood loss and transfusion requirements were significantly reduced in the period after rFVIIa administration. A highly significant reduction in hourly blood loss was found at -1 hr vs. 0 hrs and 0 hrs vs. 1 hr (-194 and -77.5 mL, respectively; both adjusted p < .001). In addition, significant improvements of international normalized ratio (p < .001), partial thromboplastin time (p < .001), platelet count (p < .001), fibrinogen (p < .001), and antithrombin (p < .001) were detected after rFVIIa administration. The two groups did not differ regarding adverse events.
  
  
  CONCLUSIONS
  rFVIIa was successfully used as an additional therapy both during and after acute aortic dissection surgery with deep hypothermic circulatory arrest, when bleeding was refractory to conventional methods. Randomized studies are necessary to confirm the safety and efficacy of rFVIIa in this setting.
authors.affiliation: Department of Anesthesiology and Intensive Care, University of Rome La Sapienza, Rome, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Tritapepe
authors.forename: Vincenzo
authors.initials: V
authors.lastname: De Santis
authors.forename: Domenico
authors.initials: D
authors.lastname: Vitale
authors.forename: Cecilia
authors.initials: C
authors.lastname: Nencini
authors.forename: Fabio
authors.initials: F
authors.lastname: Pellegrini
authors.forename: Giovanni
authors.initials: G
authors.lastname: Landoni
authors.forename: Federico
authors.initials: F
authors.lastname: Toscano
authors.forename: Fabio
authors.initials: F
authors.lastname: Miraldi
authors.forename: Paolo
authors.initials: P
authors.lastname: Pietropaoli
mesh_terms: D000784:Aortic Dissection / Q000601:surgery*; D001014:Aortic Aneurysm / Q000601:surgery*; D002315:Cardiopulmonary Bypass / Q000009:adverse effects; D003029:Coagulants / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D015942:Factor VIIa / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007036:Hypothermia, Induced / Q000009:adverse effects; D016015:Logistic Models; D008297:Male; D016555:Matched-Pair Analysis; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000188:drug therapy* / Q000209:etiology; D011994:Recombinant Proteins; D016019:Survival Analysis; D013923:Thromboembolism / Q000139:chemically induced
chemical_list: D003029:Coagulants; D011994:Recombinant Proteins; D015942:Factor VIIa