Treatment of Congenital Factor VII Deficiency with a New Concentrate

A commercial factor VII concentrate, made from ACD plasma by a process involving successive adsorptions of cryoprecipitate supernatant on DEAE Sephadex and of the resulting supernatant on A1(0H)3 was administered to 10 patients with severe factor VII deficiency.5 patients received only one dose for treatment of single bleeding episodes, the remaining 5 were given multiple doses (47) for spontaneous hemorrhages or for the prevention of surgical bleeding. The factor VII recovery in vivo ranged from 43 to 126% (average 88%) of the assayed in vitro activity of the concentrate. A dose of 0.5 factor VII u/Kg b.w. was found to produce a 1% rise of plasma factor VII level. The mean half-life of injected factor VII as assessed in 7 kinetic studies was 205 min (range 168-234). Spontaneous bleeding was easily controlled by the concentrate and major surgical procedures (two tonsillectomies) could be performed without complications. One patient developed HB_sAg positive hepatitis, but otherwise no serious side effects were observed. Factor VII concentrate reduces the risk of precipitating circulatory overload associated with the use of plasma and avoids the unnecessary rise of factor II, IX and X which follows prothrombin complex concentrates while still achieving hemostatic factor VII levels.