The authors present a series of 328 patients with severe trauma that received > 8 units of red blood cell concentrate within 12 hours and who received or did not receive recombinant activated factor VII (rFVIIa). They observe that the 72 patients who received rFVIIa had a better 24-hour survival compared to those that did not receive rFVIIa (odds ratio 2.65, 95% confidence interval 1.26-5.59, p=0.01) but in-hospital survival was not different between the two groups. They did not observe differences in clinically relevant thromboembolic events.
Recombinant factor VIIa is frequently used “off label” in trauma patients with excessive blood loss. Hence, the subject of this study is important and relevant and the study contains a very large sample of patients. However, there are quite some pitfalls in this report. The data were collected retrospectively and it was not clear what the criteria for the use of rFVIIa was. Hence, the groups may have been significantly different, which is also confirmed by the baseline characteristics. Also, dose regimens of rFVIIa were not defined and variable in different patients. Recombinant factor VIIa could also be demonstrated to be of benefit in the first 24 hours after multivariate correction and the lack of a difference in in-hospital mortality makes this difference anyhow less relevant. The lack of thromboembolic complications is important; however, it seems that this was not systematically assessed in the patients in this study.
Hence, the conclusion of the authors that the use of recombinant factor VIIa in patients with severe trauma “remains highly questionable” is understandable and confirms the results of previous randomized controlled trials with rFVIIa in trauma patients.
– Marcel Levi