Yet another case series (n=30) suggesting that rFVIIa “appears to be safe and is effective in reducing red blood cell and product transfusion requirements…” On the other hand, the results of a recently published randomized controlled trial in Circulation (2009;120:21-27) on the use of rFVIIa to control excessive bleeding after cardiac surgery concluded that “rFVIIa may be beneficial for treating bleeding after cardiac surgery, but caution should be applied and further clinical trials are required because there is an increase in the number of critical serious adverse events, including stroke, in those patients randomized to receive rFVIIa”.
We need more well-conducted, randomized controlled trials to settle these important issues. At this point in time, case series provide little or no valuable additional information.

– Jean-Franois Hardy