title: Thrombotic events in neonates receiving recombinant factor VIIa or fresh frozen plasma.
abstract: BACKGROUND
  Numerous recent reports have described the use of recombinant factor VIIa (rFVIIa) in non-hemophilia bleeding situations for achievement of hemostasis. However, its use in clinical situations other than hemophilia patients with inhibitors has been complicated by some reports of thrombotic events. rFVIIa has been used successfully to treat coagulopathic and/or bleeding neonates. The prevalence of thrombotic events in these neonates is completely unknown. This study was initiated to determine the risk of thrombotic events associated with rFVIIa use in neonates.
  
  
  METHODS
  All published literature in non-hemophilic, non-congenital factor VII deficient neonates receiving rFVIIa was reviewed. In addition, all data submitted to the SeveN Bleep Registry, a web-based registry of rFVIIa uses in non-hemophilic children was analyzed. As the baseline risk of thrombotic events in bleeding and/or coagulopathic neonates is not known, we also reviewed the records of 100 consecutive neonates from a single institution who received fresh frozen plasma (FFP) alone to treat their coagulopathy and/or bleeding episode.
  
  
  RESULTS
  A total of 134 neonates received rFVIIa. Of these, 10 (7.5%) had a thrombotic event. The baseline risk of thrombotic events in neonates receiving FFP was 7%.
  
  
  CONCLUSIONS
  Overall the prevalence of thrombotic events in bleeding and/or coagulopathic neonates appears to be around 7%, whether or not they receive rFVIIa.
authors.affiliation: Division of Hematology/Oncology, Department of Pediatrics, Saint Louis University, SSM Cardinal Glennon Children's Medical Center, St. Louis, Missouri 63104, USA. puetzjj@slu.edu
authors.forename: John
authors.initials: J
authors.lastname: Puetz
authors.forename: Ginger
authors.initials: G
authors.lastname: Darling
authors.forename: Petr
authors.initials: P
authors.lastname: Brabec
authors.forename: Jan
authors.initials: J
authors.lastname: Blatny
authors.forename: Prasad
authors.initials: P
authors.lastname: Mathew
mesh_terms: D016913:Blood Component Transfusion / Q000009:adverse effects*; D015942:Factor VIIa / Q000009:adverse effects*; D006470:Hemorrhage / Q000150:complications / Q000628:therapy; D006801:Humans; D007231:Infant, Newborn; D010949:Plasma; D015995:Prevalence; D011994:Recombinant Proteins / Q000009:adverse effects; D012306:Risk; D013223:Statistics as Topic; D013927:Thrombosis / Q000453:epidemiology / Q000209:etiology*
chemical_list: D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa