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The use of recombinant factor VIIa as a haemostatic agent in ICU patients


Recombinant factor VIIa (rFVIIa) is a prohaemostatic agent that has successfully been used for the treatment of patients with haematological malignancies and coagulopathy. It also has been used in postsurgical patients where the coagulopathy in combination with hypothermia and metabolic acidosis causes an increase of mortality early post operation. Recently reported has been the use of rFVIIa in patients with a normal coagulation system, undergoing major surgery in order to reduce the intraoperative bleeding and the need for transfusions. Here we present our experience on rFVIIa use in ICU patients.

Patients and methods

In the period from January 2002 to December 2003, 16 ICU patients received recombinant factor VIIa (10 men and six women, with the average age of 62.62 years). Of these 16 patients, 10 were admitted in ICU post operation and the reason for rFVIIa administration was severe bleeding, despite surgical intervention and massive blood component transfusions. rFVIIa was administered in six patients who had haematological malignancies, in five of them to reduce coagulation disorders and in one patient with coagulopathy, before undergoing an invasive therapeutic procedure in order to prevent bleeding. These patients were infused with 15–90 μg/kg body weight rFVIIa. To evaluate the treatment, the prothrombin time, the activated partial thromboplastin time (aPTT), and the fibrinogen level were measured, as well as number of blood components transfused before and after rFVIIa administration. The success of rFVIIa treatment was confirmed by clinical stabilization and outcome.


See Table 1 for the mean values before and after rFVIIa infusion. There were no adverse effects observed. Bleeding was controlled in 14 patients (87.5%). From these 14 patients five died (35.71%) and the reason was multiple organ dysfunction. Two patients, despite the high doses of rFVIIa, died because of continuing bleeding (12.5%).

Table 1 Table


These results show that after treatment with rFVIIa, coagulation parameters and blood requirements were all decreased. The use of rFVIIa in ICU patients is a safe and effective method to control life-threatening bleeding that cannot be managed surgically.

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Vernikos, P., Xanthis, D., Georgiou, S. et al. The use of recombinant factor VIIa as a haemostatic agent in ICU patients. Crit Care 8 (Suppl 1), P135 (2004).

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