title: Applicability and safety of recombinant activated factor VII to control non-haemophilic haemorrhage: investigational experience in 265 children.
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 < or =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 microg kg(-1) body weight (range 9.0-393.4) and the median total dose received 100.0 microg 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.
authors.affiliation: Shackleton Department of Anaesthesia, Southampton University Hospitals NHS Trust, Southampton, UK.
authors.forename: M
authors.initials: M
authors.lastname: Herbertson
authors.forename: G
authors.initials: G
authors.lastname: Kenet
mesh_terms: D000293:Adolescent; D001780:Blood Coagulation Tests; D002648:Child; D002675:Child, Preschool; D003029:Coagulants / Q000009:adverse effects / Q000627:therapeutic use*; D003102:Colloids / Q000008:administration & dosage; D000077324:Crystalloid Solutions; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D015942:Factor VIIa / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006470:Hemorrhage / Q000097:blood / Q000188:drug therapy*; D006489:Hemostatic Techniques; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007552:Isotonic Solutions / Q000008:administration & dosage; D008297:Male; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D003029:Coagulants; D003102:Colloids; D000077324:Crystalloid Solutions; D007552:Isotonic Solutions; D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa