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A pilot double blind randomized placebo controlled trial of the use of recombinant factor VIIa (rfVIIa) in high transfusion risk cardiac surgery: 009

Diprose, P.; Herbertson, M.; O'Shaughnessy, D.; Gill, R.

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European Journal of Anaesthesiology: June 2004 - Volume 21 - Issue - p 9
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Introduction: Peri-operative bleeding can be severe in patients undergoing complex cardiac surgery. The causes for this are multi-factorial. As would be expected, initial open label reports of the use of rFVIIa after cardiac surgery were encouraging [1,2]. We report the first double blind randomized use of this novel haemostatic agent in the setting of cardiac surgery.

Method: After instituitional approval and informed consent, 20 patients were randomized to receive either placebo or 90 mcg/kg of rFVIIa after protamine following the end of CPB. Patients were included if they were scheduled to have surgery with a high risk of transfusion (including double valve replacements, acute endocarditis and aortic root replacements). Primary end points were the proportion of patients exposed to blood or blood products, the total number of allogeneic units transfused per patient, and, the quantity of shed mediastinal blood. Fisher's exact test was used to compare proportions exposed to products, and, the Mann-Whitney U test for comparing number of allogeneic units exposed to each patient and mediastinal drainage.

Results: A total of 19 patients completed the study and were analysed (one patient was excluded due to protocol violation). Results are summarized in the table below.

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Discussion: rFVIIa significantly reduces transfusion requirements in complex cardiac surgery. This supports the positive reported findings of the open label compassionate use of rFVIIa in cardiac surgery. rFVIIa has a well defined place in the management of the haemophiliac patient with inhibitors. This study begins to define possible new indications for its use. Further studies in this area are required.


1 Hendriks HG, van der Maaten JM, de Wolf J, et al. An effective treatment of severe intractable bleeding after valve repair by one single dose of activated recombinant factor VII. Anesth. Analg. 2001; 93: 287-289.
2 Al Douri M, Shafi T, Al Khudairi D, et al. Effect of the administration of recombinant activated factor VII (rFVIIa; NovoSeven) in the management of severe uncontrolled bleeding in patients undergoing heart valve replacement surgery. Blood Coagul. Fibrinolysis 2000; 11 (Suppl 1): S121-S127.
© 2004 European Society of Anaesthesiology