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Effectiveness and safety of recombinant activated factor


Patients with severe and persistent bleeding have high mortality. rFVIIa has been approved for the prophylaxis and treatment of the following types of hemorrhages: in patients with inhibitors of the coagulation, with congenital deficiency of FVII and with Glanzmann thrombasthenia. The aim of the study was to evaluate the role of rFVIIa on blood transfusion requirements and its safety. Recently there have been reports of this use in refractory severe hemorrhage (liver transplantation, trauma patients, upper GI bleeding, intracerebral hemorrhage).

Materials and methods

Retrospective analyses of all the patients admitted to our hospital who received rFVIIa as treatment for severe bleeding and failure to standard therapy for massive hemorrhage, between January 2000 and November 2005, were made in this study. We obtained for all our patients: demographic data, cause of admission, cause of the hemorrhagic episode and the total doses of rVIIa. We analyzed the total number of blood products administered before and after rVIIa, the coagulation parameters, the adverse effects of rFVIIa and the mortality. We performed statistical analysis using the Wilcoxon test and considered statistical significance for P < 0.05.


A total of 30 patients fulfilling the definition of massive hemorrhage were included. Their mean age was 54.4 years. In two of 30 patients rFVIIa was used as preoperative prophylaxis in high-risk surgeries. rFVIIa was administered using the standard dosage: as an initial bolus of 60–90 μg/kg, and with repeated doses as needed for clinical control of hemorrhage (between one and three doses with 2–6 hour intervals). We were able to control the hemorrhage in 68.4% of our patients. Also the total number of packed red blood cell units decreased from 11 to 3 U per patient (P < 0.014). Moreover the administration of fresh frozen plasma decreased from an average of 7 to 1 U (P < 0.044). The total number of platelets units decreased but was not statistically significant (P = 0.07). The transfusion of rFVIIa also caused an improvement of the coagulation parameters, especially the prothrombin time (P < 0.004). We observed adverse effects in three patients (one ischemic stroke and two cardiac tamponades), although a direct association to the use of rFVIIa could not be made. Mortality at 30 days was 58%.


The administration of rFVIIa in our patients with massive hemorrhage appears to decrease the transfusional requirements, although this is only a retrospective descriptive analysis. In our experience rFVIIa seems to be a fairly safe drug, although this is not a safety study.

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Echarri González, G., Lafuente, A., Hernández, M. et al. Effectiveness and safety of recombinant activated factor. Crit Care 10 (Suppl 1), P170 (2006).

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