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Administration of Recombinant Activated Factor VII in Major Thoracic Operations—Reply

Administration of Recombinant Activated Factor VII in Major Thoracic Operations—Reply In reply This response to our article addresses an interesting point. Prophylactic treatment with rFVIIa was found to be ineffective in some surgical settings, where major bleeding was not the rule. Of course, every randomized controlled trial (RCT) needs adequate power to detect significant differences between treatment and control groups. In this case, the outcome variables usually considered are (1) the allogeneic blood-product transfusion rate, (2) the amount of allogeneic blood products used, and (3) the amount of perioperative bleeding. In their experience, Alavi and coworkers could not find any beneficial effect of rFVIIa in thoracic operations. To better address and comment on their findings, of course, it would be necessary to know the details of their RCT. Namely, it would be very important to know the preoperative profile of the patients and their historic transfusional needs and perioperative bleeding data. Moreover, we would need to know exactly which kind of thoracic operations were included in the trial. In our experience, elective thoracic surgery is not accompanied by severe perioperative bleeding (unless we consider thoracic vascular procedures within this setting) or huge transfusional needs. We are therefore inclined to attribute the lack of efficacy of rFVIIa detected by Alavi and coworkers to a low statistical power of their RCT. This problem is quite common in the existing literature on rFVIIa in surgical procedures. Lodge and coworkers1 did not find any difference between treated and control patients in a clinical setting where the mean transfusion rate ranged from 30% to 40%. For this reason, our meta-analysis was focused on major operations. In conclusion, no specific comments can be added until the study by Alavi and coworkers is published. We look forward to reading it. Correspondence: Dr Ranucci, Department of Cardiothoracic Anesthesia and Intensive Care, IRCCS Policlinico San Donato, Via Morandi 30, San Donato Milanese, Milan 20097, Italy (cardioanestesia@virgilio.it). Financial Disclosure: None reported. References 1. Lodge JPJonas SOussoultzoglou E et al. Recombinant coagulation factor VIIa in major liver resection: a randomized, placebo-controlled, double-blind clinical trial. Anesthesiology 2005;102 (2) 269- 275PubMedGoogle ScholarCrossref http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Archives of Surgery American Medical Association

Administration of Recombinant Activated Factor VII in Major Thoracic Operations—Reply

Archives of Surgery , Volume 143 (10) – Oct 20, 2008

Administration of Recombinant Activated Factor VII in Major Thoracic Operations—Reply

Abstract

In reply This response to our article addresses an interesting point. Prophylactic treatment with rFVIIa was found to be ineffective in some surgical settings, where major bleeding was not the rule. Of course, every randomized controlled trial (RCT) needs adequate power to detect significant differences between treatment and control groups. In this case, the outcome variables usually considered are (1) the allogeneic blood-product transfusion rate, (2) the amount of allogeneic blood products...
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Publisher
American Medical Association
Copyright
Copyright © 2008 American Medical Association. All Rights Reserved.
ISSN
0004-0010
eISSN
1538-3644
DOI
10.1001/archsurg.143.10.1021-b
Publisher site
See Article on Publisher Site

Abstract

In reply This response to our article addresses an interesting point. Prophylactic treatment with rFVIIa was found to be ineffective in some surgical settings, where major bleeding was not the rule. Of course, every randomized controlled trial (RCT) needs adequate power to detect significant differences between treatment and control groups. In this case, the outcome variables usually considered are (1) the allogeneic blood-product transfusion rate, (2) the amount of allogeneic blood products used, and (3) the amount of perioperative bleeding. In their experience, Alavi and coworkers could not find any beneficial effect of rFVIIa in thoracic operations. To better address and comment on their findings, of course, it would be necessary to know the details of their RCT. Namely, it would be very important to know the preoperative profile of the patients and their historic transfusional needs and perioperative bleeding data. Moreover, we would need to know exactly which kind of thoracic operations were included in the trial. In our experience, elective thoracic surgery is not accompanied by severe perioperative bleeding (unless we consider thoracic vascular procedures within this setting) or huge transfusional needs. We are therefore inclined to attribute the lack of efficacy of rFVIIa detected by Alavi and coworkers to a low statistical power of their RCT. This problem is quite common in the existing literature on rFVIIa in surgical procedures. Lodge and coworkers1 did not find any difference between treated and control patients in a clinical setting where the mean transfusion rate ranged from 30% to 40%. For this reason, our meta-analysis was focused on major operations. In conclusion, no specific comments can be added until the study by Alavi and coworkers is published. We look forward to reading it. Correspondence: Dr Ranucci, Department of Cardiothoracic Anesthesia and Intensive Care, IRCCS Policlinico San Donato, Via Morandi 30, San Donato Milanese, Milan 20097, Italy (cardioanestesia@virgilio.it). Financial Disclosure: None reported. References 1. Lodge JPJonas SOussoultzoglou E et al. Recombinant coagulation factor VIIa in major liver resection: a randomized, placebo-controlled, double-blind clinical trial. Anesthesiology 2005;102 (2) 269- 275PubMedGoogle ScholarCrossref

Journal

Archives of SurgeryAmerican Medical Association

Published: Oct 20, 2008

Keywords: thoracic surgery procedures,recombinant coagulation factor viia

References