Recombinant, activated factor VII for surgery in factor VII deficiency: a prospective evaluation - the surgical STER.

Abstract

Excessive bleeding represents a major complication of surgical interventions and its control is especially relevant in patients with Congenital Bleeding Disorders (CBD). In factor VII (FVII) deficiency, scanty data on surgery is available to guide treatment strategies. The STER (Seven Treatment Evaluation Registry) is a multi-centre, prospective, observational, web-based study protocol providing the frame for a structured and detailed data collection. Inhibitor occurrence was checked in a centralized fashion. Forty-one surgical operations (24 'major' and 17 'minor') were performed in 34 subjects with a carefully characterized FVII deficiency under the coverage of recombinant activated Factor VII (rFVIIa). Bleeding occurred during three major interventions of orthopaedic surgery, but rFVIIa was given at very low dose in each case. An antibody to FVII was observed in one patient who underwent a multiple dental extraction. No thromboses were reported during the 30-d follow up period. Replacement therapy with rFVIIa proved effective when suitable doses were used, which, during the period of maximum bleeding risk (the day of operation), were calculated (Receiver Operated Characteristic analysis) to be of at least 13 μg/kg/body weight per single dose and no less than three administrations. This indication is important especially in the case of major surgery.

• Authors: Guglielmo Mariani, Alberto Dolce, Angelika Batorova, Günter Auerswald, Jean Francois Schved, Sergio Siragusa, Mariasanta Napolitano, Jens Bjerre Knudsen, Jørgen Ingerslev, STER and the International Factor VII Deficiency Study Groups
• Journal: British journal of haematology (Br J Haematol) Vol. 152 Issue 3 Pg. 340-6 (Feb 2011) ISSN: 1365-2141 [Electronic] England
• PMID: 21158750 (Publication Type: Journal Article)
• Copyright: © 2010 Blackwell Publishing Ltd.

Chemical References

• Coagulants
• Recombinant Proteins
• recombinant FVIIa
• Factor VIIa

Topics

• Adolescent
• Adult
• Aged
• Blood Loss, Surgical (prevention & control)
• Child
• Child, Preschool
• Coagulants (therapeutic use)
• Drug Evaluation (methods)
• Epidemiologic Methods
• Factor VII Deficiency (complications, drug therapy)
• Factor VIIa (therapeutic use)
• Female
• Hemostasis, Surgical (methods)
• Humans
• Infant
• Male
• Middle Aged
• Prospective Studies
• Recombinant Proteins (therapeutic use)
• Treatment Outcome