title: Predicting response to rFVIIa in neonates with intractable bleeding or severe coagulation disturbances.
abstract: BACKGROUND
  To date, clinical experience with recombinant factor VIIa (rFVIIa) in neonates is rather limited because of the lack of controlled studies. ΑIM: The objective of this study was to present further experience from our center with regard to the use of rFVIIa in newborns with severe bleeding or coagulopathy resistant to conventional therapy and to determine factors affecting the clinical outcome.
  
  
  METHODS
  We performed a retrospective data analysis of 29 neonates with intractable bleeding or severe coagulation disturbances. All patients received 100 μg/kg of rFVIIa per dose bolus intravenously (maximum of 23 doses), as rescue procedure after other interventions had failed to achieve hemostasis.
  
  
  RESULTS
  Fourteen neonates survived (group A), whereas 15 died (group B). There was no difference in birth weight, gestational age, and bleeding site and causes between the 2 groups. In the neonates who survived, rFVIIa had been administered earlier in the disease process (<24 h of beginning of bleeding) compared with those who died (P=0.009). In all 29 neonates, international normalized ratio was directly restored (from 2.99±1.4 before rFVIIa administration to 1.6±1.1 afterward, P<0.001) and prothrombin time and activated partial thromboplastin time were significantly decreased after administration of rFVIIa (from 28 to 16.4 and from 180 to 67, respectively; P=0.001 and 0.05, respectively). Blood products administered were significantly less in group A than in group B, as time from the beginning of bleeding to the administration of rFVIIa was significantly less in group A than in group B. Neither acute adverse events nor thromboembolic complications were observed.
  
  
  CONCLUSIONS
  In this neonatal group with intractable bleeding and/or severe coagulation disturbances, rFVIIa was more effective in early intervention as rescue therapy, without any adverse events in all neonates. Upon failure to achieve hemostasis with initial administration of blood products, fast intervention with rFVIIa could be considered in neonates with serious bleeding and coagulation disorders.
authors.affiliation: Neonatal Intensive Care Unit and Neonatal Department, Aristotle University of Thessaloniki, Thessaloniki, Greece.
authors.forename: Evangelia
authors.initials: E
authors.lastname: Gkiougki
authors.forename: Georgios
authors.initials: G
authors.lastname: Mitsiakos
authors.forename: Elias
authors.initials: E
authors.lastname: Chatziioannidis
authors.forename: Emmanouel
authors.initials: E
authors.lastname: Papadakis
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Nikolaidis
mesh_terms: D001778:Blood Coagulation Disorders / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D015942:Factor VIIa / Q000627:therapeutic use*; D005260:Female; D005865:Gestational Age; D006470:Hemorrhage / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D020714:Maximum Tolerated Dose; D011379:Prognosis; D011994:Recombinant Proteins / Q000627:therapeutic use*; D012189:Retrospective Studies; D012307:Risk Factors
chemical_list: D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa