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

被引:68
作者
Mariani, Guglielmo [1 ]
Dolce, Alberto [2 ]
Batorova, Angelika [3 ]
Auerswald, Guenter [4 ]
Schved, Jean Francois [5 ]
Siragusa, Sergio [6 ]
Napolitano, Mariasanta [1 ]
Knudsen, Jens Bjerre [7 ]
Ingerslev, Jorgen [8 ]
机构
[1] Univ Aquila, Dept Internal Med & Publ Hlth, I-67100 Laquila, Italy
[2] Natl Inst Stat, Rome, Italy
[3] Univ Hosp, Natl Haemophilia Ctr, Inst Haematol & Blood Transfus, Bratislava, Slovakia
[4] Cent Hosp, Dept Pediat, Bremen, Germany
[5] CHU Montpellier, Haemophilia Ctr, Montpellier, France
[6] Univ Palermo, I-90133 Palermo, Italy
[7] Novo Nordisk AS Bagsvaerd, Med & Sci Haematol, Bagsvaerd, Denmark
[8] Aarhus Univ Hosp, Ctr Haemophilia & Thrombosis, DK-8000 Aarhus N, Denmark
关键词
surgery; replacement therapy; factor VII deficiency;
D O I
10.1111/j.1365-2141.2010.08287.x
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
P>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 mu g/kg/body weight per single dose and no less than three administrations. This indication is important especially in the case of major surgery.
引用
收藏
页码:340 / 346
页数:7
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