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Guidelines-associated decrease in mortality with recombinant activated factor VII for refractory hemorrhage


Recombinant activated factor VII (rFVIIa; Novoseven) is indicated for treatment of bleeding in hemophilic patients with antibodies against factor VIII or factor IX. Although not licensed or agreed for other indications, its use for refractory hemorrhage is increasingly reported. We reviewed our experience with off-label use of rFVIIa in this indication.


We retrospectively reviewed all patients treated with rFVIIa from March 2004 to November 2008 in our hospital. Those included in a multicentric study (n = 10) or treated within approved (n = 3) or nonhemorrhage (n = 4) indications were excluded. Initial use imposed constringent guidelines implementation. According to these, use of rFVIIa requires cross-checking for active correction of hypothermia, acidosis, and coagulation factors and consideration for any feasible haemostatic surgery or embolisation.


Forty-two patients were included. Median age was 39 years and 60% were male. The underlying condition was trauma in 14% of cases and surgery-associated hemorrhage in 76%. Bleeding stopped in 79% of cases. Potentially associated thromboembolic complications were observed in five (11.9%) cases, only one being very probably linked to rFVIIa. The overall 30-day mortality was 40.5%. The initial experience was followed by a decline in the use of rFVIIa, and the release of guidelines followed by a continuous increase. We observed a progressive decline in the 30-day mortality rate, from 70% in the first 10 patients to 17% in the last 10 (Figure 1). The average number of blood transfusions before rFVIIa remained stable but the median rFVIIa doses decreased from 206 μg/kg in the first 10 patients to 80 μg/kg in the last 10.

Figure 1
figure 1

Thirty-day mortality after rFVIIa.


Local guidelines release did not decrease the number of cases but seem to impact on when and to whom rFVIIa is administered. Their release, associated with increasing experience, was associated with a striking lowering of mortality rate.

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Schneider, A., Voirol, P., Perez, M. et al. Guidelines-associated decrease in mortality with recombinant activated factor VII for refractory hemorrhage. Crit Care 13 (Suppl 1), P428 (2009).

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  • Blood Transfusion
  • Coagulation Factor
  • Continuous Increase
  • Active Correction
  • Underlying Condition