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.
Harrison, T. D., Laskosky, J., Jazaeri, O., Pasquale, M. D., & Cipolle, M. (2005). "Low-dose" recombinant activated factor VII results in less blood and blood product use in traumatic hemorrhage. The Journal Of Trauma, 59(1), 150-154.