title: Treatment of refractory bleeding after cardiac operations with low-dose recombinant activated factor VII (NovoSeven): a propensity score analysis.
abstract: BACKGROUND
  Recombinant activated factor VII (rFVIIa) has been increasingly used to stop life-threatening bleeding following cardiac operations. Nonetheless, the issue of dosing, given the expense and potential for thrombotic complications, is still of major concern. We report our experience with small-dose rFVIIa in patients with refractory bleeding after cardiac surgery.
  
  
  RESULTS
  From September 2005 to June 2007, 40 patients (mean age 70.1+/-9.2 years, 52.5 males) received a low dose of rFVIIa (median: 18 microg/kg, interquartile range: 9-16 microg/kg) for refractory bleeding after cardiac surgery. Forty propensity score-based greedy matched controls were compared to the study group. Low dose of rFVIIa significantly reduced the 24-h blood loss: 1610 ml [ 1285-1800 ml] versus 3171 ml [2725-3760 ml] in the study and control groups, respectively (p<0.001). Thus, hourly bleeding was 51.1 ml [34.7-65.4 ml] in patients receiving rFVIIa and 196.2 ml/h [142.1-202.9 ml] in controls (p<0.001). Furthermore, patients receiving rFVIIa showed a lower length of stay in the intensive care unit (p<0.001) and shorter mechanical ventilation time (p<0.001). In addition, the use of rFVIIa was associated with reduction of transfusion requirements of red blood cells, fresh frozen plasma and platelets (all, p<0.001). Finally, treated patients showed improved hemostasis with rapid normalization of coagulation variables (partial thromboplastin time, international normalized ratio, platelet count, p<0.001). In contrast, activated prothrombin time and fibrinogen did not differ between groups (p=ns). No thromboembolic-related event was detected in our cohort.
  
  
  CONCLUSIONS
  In our experience low-dose rFVIIa was associated with reduced blood loss, improvement of coagulation variables and decreased need for transfusions. Our findings need to be confirmed by further larger studies.
authors.affiliation: Experimental Surgery Unit, Department of Heart and Vessels, Careggi Hospital, Florence, Italy. sandro.gelsomino@libero.it
authors.forename: Sandro
authors.initials: S
authors.lastname: Gelsomino
authors.forename: Roberto
authors.initials: R
authors.lastname: Lorusso
authors.forename: Stefano
authors.initials: S
authors.lastname: Romagnoli
authors.forename: Sergio
authors.initials: S
authors.lastname: Bevilacqua
authors.forename: Giuseppe
authors.initials: G
authors.lastname: De Cicco
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Billè
authors.forename: Pierluigi
authors.initials: P
authors.lastname: Stefàno
authors.forename: Gian Franco
authors.initials: GF
authors.lastname: Gensini
mesh_terms: D000368:Aged; D001803:Blood Transfusion / Q000191:economics / Q000706:statistics & numerical data; D006348:Cardiac Surgical Procedures / Q000009:adverse effects*; D003029:Coagulants / Q000008:administration & dosage* / Q000191:economics; D004305:Dose-Response Relationship, Drug; D015942:Factor VIIa / Q000008:administration & dosage* / Q000191:economics; D005260:Female; D006801:Humans; D008297:Male; D019106:Postoperative Hemorrhage / Q000188:drug therapy*; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000191:economics; D016896:Treatment Outcome
chemical_list: D003029:Coagulants; D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa