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Thrombotic events in neonates receiving recombinant factor VIIa or fresh frozen plasma.

AbstractBACKGROUND: 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. PROCEDURE: 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.
AuthorsJohn Puetz, Ginger Darling, Petr Brabec, Jan Blatny, Prasad Mathew (Affiliation: Division of Hematology/Oncology, Department of Pediatrics, Saint Louis University, SSM Cardinal Glennon Children's Medical Center, St. Louis, Missouri 63104, USA. puetzjj at slu.edu)
JournalPediatric blood & cancer (Pediatr Blood Cancer) Vol. 53 Issue 6 Pg. 1074-8 (Dec 2009) ISSN: 1545-5017 [Electronic] United States
PMID19621430 (Publication Type: Journal Article, Review)
Chemical References
  • Recombinant Proteins
  • recombinant FVIIa
  • Factor VIIa
Topics
  • Blood Component Transfusion (adverse effects)
  • Factor VIIa (adverse effects)
  • Hemorrhage (complications, therapy)
  • Humans
  • Infant, Newborn
  • Plasma
  • Prevalence
  • Recombinant Proteins (adverse effects)
  • Risk
  • Statistics as Topic
  • Thrombosis (epidemiology, etiology)