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    Management of the Sponataneous Bleeding Episodes in Factor VII Deficiency. A Prospective Evaluation of the STER
    (AMER SOC HEMATOLOGY, 2011) Napolitano, Mariasanta; Dolce, Alberto; Batorova, Angelika; Auerswald, Guenter K. H.; Schved, Jean-Francois; Siragusa, Sergio; Knudsen, Jens Bjerre
    [Abstract not Available]
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    Prophylaxis In Congenital Factor VII Deficiency, Indications, Efficacy and Safety: Results of the STER
    (AMER SOC HEMATOLOGY, 2010) Napolitano, Mariasanta; Giansily-Blaizot, Muriel; Dolce, Alberto; Schved, Jean-Francois; Auerswald, Guenter; Ingerslev, Jorgen; Bjerre, Jens; Altisent, Carmen; Charoenkwan, Pimlak; Michaels, Lisa; Chuansumrit, Ampaiwan; Di Minno, Giovanni; Çalışkan, Ümran; Mariani, Guglielmo
    [Abstract not Available]
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    Prophylaxis in congenital factor VII deficiency: indications, efficacy and safety. Results from the Seven Treatment Evaluation Registry (STER)
    (FERRATA STORTI FOUNDATION, 2013) Napolitano, Mariasanta; Giansily-Blaizot, Muriel; Dolce, Alberto; Schved, Jean F.; Auerswald, Guenter; Ingerslev, Jorgen; Bjerre, Jens
    Because of the very short half-life of factor VII, prophylaxis in factor VII deficiency is considered a difficult endeavor. The clinical efficacy and safety of prophylactic regimens, and indications for their use, were evaluated in factor VII-deficient patients in the Seven Treatment Evaluation Registry. Prophylaxis data (38 courses) were analyzed from 34 patients with severe factor VII deficiency (<1-45 years of age, 21 female). Severest phenotypes (central nervous system, gastrointestinal, joint bleeding episodes) were highly prevalent. Twenty-one patients received recombinant activated factor VII (24 courses), four received plasma-derived factor VII, and ten received fresh-frozen plasma. Prophylactic schedules clustered into "frequent" courses (three times weekly, n=23) and "infrequent" courses (<= 2 times weekly, n=15). Excluding courses for menorrhagia, "frequent" and "infrequent" courses produced 18/23 (78%) and 5/12 (41%) "excellent" outcomes, respectively; relative risk, 1.88; 95% confidence interval, 0.93-3.79; P=0.079. Long-term prophylaxis lasted from 1 to >10 years. No thrombosis or new inhibitors occurred. In conclusion, a subset of patients with factor VII deficiency needed prophylaxis because of severe bleeding. Recombinant activated factor VII schedules based on "frequent" administrations (three times weekly) and a 90 mu g/kg total weekly dose were effective. These data provide a rationale for long-term, safe prophylaxis in factor VII deficiency.