Recombinant activated factor VII treatment of severe bleeding in cardiac surgery patients: a retrospective analysis of dosing, and efficacy and safety outcomes

Abstract

This study describes patient characteristics, recombinant activated factor VII (RF7a) dosing and clinical outcomes of cardiovascular surgery patients treated with RF7a for intractable bleeding. Use of RF7a for postsurgical bleeding, trauma or other uses in non-hemophiliac patients is considered off-label in the USA. Comprehensive studies evaluating RF7a in cardiac surgery patients are limited. Published reports cite success with RF7a administration in massive intractable bleeding. However, patient selection, dosing, efficacy, safety and pharmacoeconomic benefit remain undefined. Patients receiving RF7a between January 2004 and September 2005 were identified via pharmacy records. Clinical databases and electronic medical records were reviewed, collecting data elements needed to assess study objectives. One hundred and twenty patients were identified. Twenty-seven patients were excluded because they lacked documentation of RF7a administration, were treated for neurologic indications or had incomplete medical record data. Ninety-three patients were analyzed. RF7a effectively achieves hemostasis in patients with intractable bleeding, reducing blood product transfusions within 6 hours of treatment (Figure ​(Figure1).1). Our findings suggest differences in PRBC transfusion reduction between RF7a doses. We observed no additional reduction PRBC transfusions in patients administered doses greater than 60–90 μg/kg (Figure ​(Figure2).2). Effects of RF7a on surgical re-exploration and other potential related adverse events (stroke, AMI, VTE, etc.) are forthcoming. Our study, like others evaluating RF7a for this indication, are limited by the retrospective scope. Randomized trials comparing RF7a doses are under way. Although RF7a therapy is costly, minimal reductions in surgical re-exploration may offset the cost of RF7a therapy provided that adverse events are not increased. Figure 1 Figure 2