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Use of Recombinant, Activated Factor VII in the Treatment of Congenital Factor VII Deficiencies
Author(s) -
Mariani G.,
Testa M.G.,
Paolantonio T.,
Bech R. Molskov,
Hedner U.
Publication year - 1999
Publication title -
vox sanguinis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.68
H-Index - 83
eISSN - 1423-0410
pISSN - 0042-9007
DOI - 10.1046/j.1423-0410.1999.7730131.x
Subject(s) - factor vii , medicine , coagulation , prothrombin complex concentrate , recombinant dna , prothrombin time , dose , recombinant factor viia , prothrombin complex , coagulopathy , surgery , body weight , gastroenterology , warfarin , biochemistry , chemistry , gene , atrial fibrillation
Background and Objectives:Factor VII (FVII) deficiency is a rare coagulation disorder, historically treated with prothrombin complex concentrates or plasma‐derived FVII concentrates. We treated such patients (n=17) with a recombinant, activated FVII preparation. Materials and Methods: Twenty‐seven spontaneous bleeding episodes were treated and 7 major and 13 minor surgical interventions were carried out. The dosages employed ranged from 8.08 to 70.5 μg/kg body weight. Results: A mean dose between 22 and 26 μg/kg was sufficient to normalise the prothrombin time. Fifteen haemarthroses were treated with single doses and results were excellent in 13 cases. In 5/6 bleeding episodes of other types, the treatment gave either excellent or at least effective results. Haemostasis was secured in the 7 major and 13 minor surgical interventions. One patient developed antibodies 4–5 weeks after an extremely high dose. Otherwise, there were no side effects and no evidence of a thrombotic tendency. Conclusion: This recombinant concentrate is efficacious in FVII‐deficient patients. It is safe since any risk of transmission of blood‐borne viruses is eliminated.