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Applicability and safety of recombinant activated factor VII to control non‐haemophilic haemorrhage: investigational experience in 265 children
Author(s) -
HERBERTSON M.,
KENET G.
Publication year - 2008
Publication title -
haemophilia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.213
H-Index - 92
eISSN - 1365-2516
pISSN - 1351-8216
DOI - 10.1111/j.1365-2516.2008.01746.x
Subject(s) - medicine , intracranial haemorrhage , coagulopathy , surgery , recombinant factor viia , body weight , anesthesia , pediatrics , complication
Summary. 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.