Background: This study was designed to compare mortality and blood product use in patients who received recombinant activated factor VII (rFVIIa) for traumatic hemorrhage to a matched historic control.
Methods: Trauma registry data of bleeding trauma patients who received rFVIIa (40 microg/kg, repeated once if needed) included 28-day mortality; pre- and post-rFVIIa international normalized ratio; and packed red blood cell (PRBC), fresh frozen plasma, platelet, and cryoprecipitate requirements. A control group was created of bleeding patients who did not receive rFVIIa by matching for Injury Severity Score and age. The chi2 and Student's t tests were used to test for significance.
Results: Twenty-nine patients, well matched to 72 control patients, made up the rFVIIa group. rFVIIa corrected international normalized ratio within 4 hours (from 4.4 to 1.2; p < 0.0001). There was no difference in mortality (control, 40.3%; rFVIIa, 41.4%). The rFVIIa group required significantly fewer PRBC transfusions than the control group (18.3 +/- 7.5 vs. 22.0 +/- 9.7; p = 0.036). Compared with the control group, the rFVIIa group required fewer platelet transfusions (1.4 +/- 1.2 vs. 2.3 +/- 2.1; p = 0.01) and less cryoprecipitate (0.59 +/- 0.54 vs. 1.5 +/- 1.8; p = 0.006).
Conclusion: rFVIIa resulted in significantly less PRBC, platelet, and cryoprecipitate use and equivalent mortality when compared with the matched control group, with no increase in complications.