title: Recombinant activated factor VII use in critically ill patients: clinical outcomes and thromboembolic events.
abstract: BACKGROUND
  Hemorrhage and coagulopathy are associated with morbidity and mortality in critically ill patients. Recombinant activated factor VII (rFVIIa) is frequently used in these situations to control bleeding; however, few controlled clinical trials have demonstrated clinical benefit and prolonged survival.
  
  
  OBJECTIVE
  To compare clinical outcomes and thromboembolic events in intensive care unit (ICU) patients who received rFVIIa versus ICU patients who did not between 2000 and 2005.
  
  
  METHODS
  A total of 2918 nonhemophiliac adult ICU patients, which included 1459 who received at least 1 dose of rFVIIa and 1459 matched controls who did not, were included in a retrospective database study. Data were extracted from the Solucient ACTracker database, which included 550 hospitals across the US. Measures included patient demographics, rFVIIa prescribing, death, thromboembolic events, discharge disposition, length of stay, and transfusion data.
  
  
  RESULTS
  The most common primary diagnoses for patients receiving rFVIIa included traumatic brain injury, cirrhosis, and nontraumatic intracranial hemorrhage. Patients receiving rFVIIa were more likely to have comorbidities, including mechanical ventilation, acute kidney injury, sepsis, hemodialysis, and gastrointestinal bleeding (p < 0.0001). The average rFVIIa dose was 4.8 mg and 82% of patients received 1 dose. Compared to controls, patients receiving rFVIIa had greater odds of death (OR 2.1, 95% CI 1.8-2.6, p < 0.0001), transfusion (OR 2.1, 95% CI 1.8-2.5, p < 0.0001), and longer length of stay (p < 0.001). There was no significant difference in thromboembolic events between groups.
  
  
  CONCLUSIONS
  While we cannot show direct causality between rFVIIa and the poor clinical outcomes documented in ICU patients, they provide important insight for critical care clinicians.
authors.affiliation: Department of Pharmacotherapy & Outcomes Science, Virginia Commonwealth University, Richmond, VA, USA.
authors.forename: Gretchen M
authors.initials: GM
authors.lastname: Brophy
authors.forename: Christina L
authors.initials: CL
authors.lastname: Candeloro
authors.forename: Jaime R
authors.initials: JR
authors.lastname: Robles
authors.forename: Donald F
authors.initials: DF
authors.lastname: Brophy
mesh_terms: D016638:Critical Illness; D015942:Factor VIIa / Q000009:adverse effects* / Q000627:therapeutic use*; D005260:Female; D006470:Hemorrhage / Q000188:drug therapy*; D006801:Humans; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012189:Retrospective Studies; D013923:Thromboembolism / Q000139:chemically induced*; D016896:Treatment Outcome
chemical_list: D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa