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Thrombotic events in neonates receiving recombinant factor VIIa or fresh frozen plasma
Author(s) -
Puetz John,
Darling Ginger,
Brabec Petr,
Blatny Jan,
Mathew Prasad
Publication year - 2009
Publication title -
pediatric blood and cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.116
H-Index - 105
eISSN - 1545-5017
pISSN - 1545-5009
DOI - 10.1002/pbc.22160
Subject(s) - medicine , fresh frozen plasma , recombinant factor viia , coagulopathy , hemostasis , surgery , factor viia , pediatrics , coagulation , platelet , tissue factor
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. 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. Pediatr Blood Cancer 2009;53:1074–1078. © 2009 Wiley‐Liss, Inc.