Treatment of refractory bleeding after cardiac operations with low-dose recombinant activated factor VII (NovoSeven®): a propensity score analysis

Sandro Gelsomino, Roberto Lorusso, Stefano Romagnoli, Sergio Bevilacqua, Giuseppe De Cicco, Giuseppe Billè, Pierluigi Stefàno, Gian Franco Gensini

Research output: Contribution to journalArticlepeer-review

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. Methods and 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 μg/kg, interquartile range: 9-16 μg/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.

Original languageEnglish
Pages (from-to)64-71
Number of pages8
JournalEuropean Journal of Cardio-thoracic Surgery
Volume33
Issue number1
DOIs
Publication statusPublished - Jan 2008

Keywords

  • Hemorrhage
  • Plasma
  • Platelet-derived factors
  • Platelets

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Surgery

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