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Life-threatening hemorrhage in neonates and children: treatment with activated recombinant factor VII

According to the small circulating blood volume, acute hemorrhage in children, especially in preterms and newborns, leads rapidly into a life-threatening event. The successful use of activated recombinant factor VII (rFVIIa) in life-threatening hemorrhage has been reported in adult critical care patients. Except for one case report, the application of rFVIIa in children has not yet been described.

We report on our experience with five preterms and neonates and two children (mean age 4 weeks, range 2 days-7 years) with acute hemorrhage, who were treated with rFVIIa (Novo Seven®; Novo Nordisk, Denmark). Prior to the acute blood loss they had no hereditary coagulation disorder nor disseminated intravascular coagulopathy. One preterm showed bleeding from an intecostal artery, whereas the manifestation in the other cases was of pulmonal (diffuse pulmonary bleeding) or abdominal origin (isolated liver bleeding, traumatic mucosal bleeding of the distal esophagus, gastrointestinal bleeding according to viscerocutaneous hemangiomatosis). All patients received rFVIIa after other attempts (treatment with fresh frozen plasma, platelet concentrate and packed red cells; surgical interventions) failed and hemorrhagic shock persisted. Except in one 7-year-old girl, within 15 min after the application or rFVIIa bleeding stopped and all patients recovered. No acute adverse event nor thromboembolic complications over a long observation period could be observed.


Application of rFVIIa in hemostasiologic healthy newborns or children with acute hemorrhage seems to be a promising therapeutical approach after other pharmacological or surgical attempts have failed.

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Fischer, D., Veldman, A., Schloesser, R. et al. Life-threatening hemorrhage in neonates and children: treatment with activated recombinant factor VII. Crit Care 7, P106 (2003).

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  • Hemorrhagic Shock
  • Acute Hemorrhage
  • Platelet Concentrate
  • Circulate Blood Volume
  • Critical Care Patient