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October 20, 2008

Administration of Recombinant Activated Factor VII in Major Thoracic Operations

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Copyright 2008 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2008

Arch Surg. 2008;143(10):1021. doi:10.1001/archsurg.143.10.1021-a

We would like to make some points regarding the valuable article by Ranucci et al1 published in the March issue of the Archives. The authors reviewed randomized clinical trials of the administration of recombinant factor VII (rFVII) in major operations. In their meta-analysis, they showed that, in major operations, rFVII can reduce use of red blood cell units. Most of these studies have been performed in cardiac operations and liver transplantation. In some major operations, such as thoracic operations, we do not have enough evidence2 about the efficacy and safety of rFVII. In a randomized controlled trial, we evaluated the effect of rFVII on 40 patients who underwent elective thoracic operations (20 of whom received 90 μg of rFVII per kilogram of bodyweight preoperatively). In our study, there were no significant differences regarding perioperative bleeding (intraoperatively and 2 days later) and use of blood products (P > .05) between the 2 groups. Also, no complications were seen. In this study, we excluded patients who needed emergency operations. Also, no patient in this study had liver disease, renal failure, or acquired or congenital bleeding disorders, which have been previously described by Filsoufi et al3 as risk factors for massive perioperative bleeding. Thus, according to our study and other articles4,5 that failed to show the efficacy of rFVII, it seems that, besides the other well-defined risk factors, type of operation (emergent or elective) is an important determinant for the efficacy of rFVII.

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