title: Massive postpartum hemorrhage: recombinant factor VIIa use is safe but not effective.
abstract: OBJECTIVE
  Postpartum hemorrhage is a leading cause of maternal mortality. Massive transfusion in obstetric patients is rare. Recombinant Factor VIIa (rFVIIa) use in trauma patients with massive transfusion is efficacious. Our goal was to evaluate the safety and efficacy of rFVIIa use in obstetric patients with massive postpartum hemorrhage (MPH).
  
  
  METHODS
  Patients records with MPH from 2003 to 2006 were reviewed. Data collected were demographics, APACHE II scores, International Normalized Ratio (INR), fibrinogen level, blood product administration, rates of pulmonary embolism (PE), deep vein thrombosis (DVT), myocardial infarction (MI), hysterectomy, and mortality. Continuous variables within groups were analyzed with paired t-test, and independent t-test between groups. Categorical variables were compared via chi2 or Fishers Exact test and significance was denoted by a p < or = 0.05.
  
  
  RESULTS
  Twenty-seven patients with MPH were investigated, eight received rFVIIa (study group) and 19 did not (control group). All patients received a massive transfusion, six units of packed red blood cells (pRBCs), via a massive transfusion protocol. The study group's mean APACHE II score 25.8 +/- 8.5, predicted mortality of 56.2 percent, was higher than control, p = 0.009. An increase in transfused units of cryoprecipitate, p < 0.001, pRBCs, p = 0.004, decrease in INR, p < 0.001, and length of stay in the high risk obstetrical unit, p = 0.019, existed in the study group. Hysterectomy was required in 85.7 percent of the study group. No patients developed a DVT, PE, or MI and all survived.
  
  
  CONCLUSIONS
  Recombinant Factor VIIa use in MPH is safe, improves coagulopathy, was not effective in decreasing blood product transfusion requirements, and may contribute to an improved predicted mortality.
authors.affiliation: Christiana Care Hospital in Newark, Del, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Kalina
authors.forename: Glen
authors.initials: G
authors.lastname: Tinkoff
authors.forename: Gerard
authors.initials: G
authors.lastname: Fulda
mesh_terms: D000328:Adult; D001803:Blood Transfusion; D017707:Erythrocyte Transfusion; D015942:Factor VIIa / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007044:Hysterectomy; D007902:Length of Stay / Q000706:statistics & numerical data; D006473:Postpartum Hemorrhage / Q000188:drug therapy* / Q000628:therapy; D011247:Pregnancy; D011250:Pregnancy Complications, Hematologic / Q000188:drug therapy*; D011994:Recombinant Proteins / Q000627:therapeutic use; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa