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Two years experience with low-dose recombined activated factor VII treatment of non-haemophilic patients


Recombined activated factor VII (rFVIIa) (NovoSeven®; Novo Nordisk) is a relatively new drug, which gives new opportunity in the treatment of patients with severe bleeding. The severe bleeding in haemophilic patients was the first indication for which rFVIIa was registered, but nowadays this drug is becoming more popular also in treatment of severe bleedings of other origins.


The aim of this research was to evaluate the effectiveness of rFVIIa in treatment of severely bleeding patients in the ICU.


Retrospective analysis of 24 patient who received rFVIIa in our ICU between January 2001 and October 2005. We used the questionnaires of Novo Nordisk to assess the indications and effectiveness of treatment. We compared the amount of blood lost within 12 hours before and within 12 hours after giving rFVIIa, and the dynamics of bleeding (assessed in ml/hours) before and after treatment.


In the aforementioned period of time rFVIIa was used 28 times in our ICU in treatment of 24 patients (four patients received two doses) with severe bleeding, none of whom was suffering haemophilia. The average patient age was 49.5 years (range 24–77), and average body mass was 70.4 kg (range 55–120). The following diseases were diagnosed: cancer – six patients (liver cancer, two patients; ovarian cancer, two patients; prostate, one patient; kidney, one patient), post-abdominal surgery bleeding -four patients, ruptured abdominal aorta aneurysms – three patients, sepsis – three patients, acute pancreatitis – two patients, post-kidney transplant complications – two patients, postpartum bleeding – two patients, GI bleeding – two patients. One of the mentioned patients with sepsis was a lady treated with drotreocogin (Xigris, Lilly) infusion. The average dose of rFVIIa was 22.53 μg/kg (range 10–56). The average blood loss within 12 hours before treatment was 2728 ml and the average blood loss within 12 hours after treatment was 184 ml. The average dynamics of bleeding before treatment was 1163 ml/hours versus 184 ml/hours after treatment. The differences between the volume of blood lost and dynamics of bleeding after and before treatment were statistically significant.


Our 4-year experience with rFVIIa makes us convinced that this drug is very useful in treatment of severely bleeding patients. It seems reasonable to start treatment with relatively low doses, which are very often efficient enough to stop bleeding, and the costs of such therapy are not so high as with higher doses.

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Michalska, G., Ratajski, R. Two years experience with low-dose recombined activated factor VII treatment of non-haemophilic patients. Crit Care 10 (Suppl 1), P164 (2006).

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