title: Analysis of Outcomes Using Low-Dose and Early Administration of Recombinant Activated Factor VII in Cardiac Surgery.
abstract: BACKGROUND
  Although not currently approved for postoperative cardiac surgical bleeding, recombinant activated factor VII (rFVIIa) has been used for this purpose. This study sought to analyze outcomes in patients who had cardiac surgical bleeding and received low-dose and early administration of rFVIIa versus outcomes in patients who had cardiac surgical bleeding and did not receive rFVIIa.
  
  
  METHODS
  Fifty-one patients receiving rFVIIa were matched, using The Society of Thoracic Surgeons morbidity and mortality scores, with 51 patients who underwent cardiac surgical procedures and met criteria for surgical bleeding. Primary outcomes were ventilator hours and intensive care unit length of stay. Secondary outcomes included 30-day mortality, acute kidney injury, postoperative hospital length of stay, thromboembolic events, postoperative pneumonia, and sternal wound infections. Reoperations for bleeding were analyzed for each group to assess for achievement of hemostasis.
  
  
  RESULTS
  The median total dose of rFVIIa was 12 mcg/kg. rFVIIa was given as the first and only treatment for bleeding in 7 of 51 (13%) patients, whereas 13 of 51 patients receiving rFVIIa (25%) also received up to 1 unit of any blood product. Patients who received rFVIIa had increased duration of mechanical ventilation (p = 0.002) and increased length of stay in the intensive care unit (p = 0.02). There were no differences in hospital length of stay, 30-day mortality, acute kidney injury, postoperative pneumonia, sternal wound infections, postoperative thromboembolic events, or rate of reoperations for bleeding.
  
  
  CONCLUSIONS
  Low-dose and early administration of rFVIIa (median total dose 12 mcg/kg) for cardiac surgical bleeding shows potential in achieving hemostasis without increased risk of thromboembolism or acute kidney injury.
authors.affiliation: Kansas University Medical Center, Kansas City, Kansas.
authors.forename: Jason
authors.initials: J
authors.lastname: Brase
authors.affiliation: Kansas University Medical Center, Kansas City, Kansas.
authors.forename: Brooke
authors.initials: B
authors.lastname: Finger
authors.affiliation: Department of Biostatistics, Kansas University Medical Center, Kansas City, Kansas.
authors.forename: Jianghua
authors.initials: J
authors.lastname: He
authors.affiliation: Department of Nursing, Kansas University Medical Center, Kansas City, Kansas.
authors.forename: Katy
authors.initials: K
authors.lastname: Wirtz
authors.affiliation: Department of Pharmacy, Kansas University Medical Center, Kansas City, Kansas.
authors.forename: Lucy
authors.initials: L
authors.lastname: Stun
authors.affiliation: Department of Pharmacy, Kansas University Medical Center, Kansas City, Kansas.
authors.forename: Randy
authors.initials: R
authors.lastname: McMillen
authors.affiliation: Department of Anesthesiology and Critical Care, Kansas University Medical Center, Kansas City, Kansas. Electronic address: brigidcflynn@yahoo.com.
authors.forename: Brigid
authors.initials: B
authors.lastname: Flynn
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D006348:Cardiac Surgical Procedures / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D005167:Factor VII / Q000378:metabolism; D015942:Factor VIIa / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007362:Intensive Care Units; D007615:Kansas / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009017:Morbidity / Q000639:trends; D019106:Postoperative Hemorrhage / Q000097:blood / Q000453:epidemiology / Q000517:prevention & control*; D011994:Recombinant Proteins / Q000008:administration & dosage; D012189:Retrospective Studies; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D055815:Young Adult
chemical_list: D011994:Recombinant Proteins; D005167:Factor VII; C103587:recombinant FVIIa; D015942:Factor VIIa