Applicability and safety of recombinant activated factor VII to control non-haemophilic haemorrhage: Investigational experience in 265 children

M. Herbertson, Gili Kenet*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Experience of recombinant activated factor VII (rFVIIa, NovoSeven®; Novo Nordisk A/S, Bagsvaerd, Denmark) to control haemorrhage in non-haemophilic children is limited. The object of this study was to examine the applicability and safety of rFVIIa amongst a group of non-haemophilic paediatric subjects. Details of all non-haemophilic children ≤16 years receiving rFVIIa whose data were recorded in the investigational, internet-based registry, haemostasis.com were analysed. A total of 265 children (mean age 7.7 years) were treated with rFVIIa; the median dose administered was 78.4 μg kg-1 body weight (range 9.0-393.4) and the median total dose received 100.0 μg kg-1 body weight (range 10.9-1341.2). Therapeutic areas included surgery (34.5%), coagulopathy (including thrombocytopenia; 29.0%), spontaneous bleeding (17.2%), trauma (8.4%) and intracranial haemorrhage (4.5%). Two patients experienced thromboembolic events following administration of rFVIIa. Thirty-nine patients died on account of haemorrhage or complications relating to their underlying condition; neither the thromboembolic events nor the deaths were related to rFVIIa administration. Bleeding stopped in 118/237 (49.8%), markedly decreased in 54/237 (22.8%), decreased in 51/237 (21.5%), remained unchanged in 13/ 237 (5.5%) and increased in 1/237 (0.4%) patients. These results suggest that rFVIIa is safe and widely applicable in children to control non-haemophilic haemorrhage.

Original languageEnglish
Pages (from-to)753-762
Number of pages10
JournalHaemophilia
Volume14
Issue number4
DOIs
StatePublished - Jul 2008
Externally publishedYes

Keywords

  • Children
  • Haemorrhage
  • Haemostasis
  • Paediatric
  • Safety
  • rFVIIa

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