Recombinant-activated factor VII in patients with uncontrolled bleeding: A retrospective observational analysis

Factor VIIa (recombinant) has an off-label use to control life-threatening bleeding that is refractory to other measures and was shown to decrease transfusion requirements.

The primary objective of this study was to assess the safety and effectiveness of factor VIIa (recombinant) on blood transfusion requirements and coagulation parameters when used in patients whose bleeding was uncorrected by other means. The pharmacoeconomic impact for any discrepancy from our protocol was evaluated. Secondary outcomes included 4-hour and 28-day mortality, as well as safety of this agent in terms of thromboembolic complications.

We retrospectively evaluated patients who received recombinant-activated factor VII (rFVIIa) for uncontrolled bleeding from June 2008 to April 2011. The medical records of 33 patients were evaluated. Coagulation parameters and blood products were determined 24 hours before and 24 hours after administration of rFVIIa, and the results compared. Patients were also screened for any thromboembolic complications.

Administration of rFVIIa reduced blood transfusion requirements and improved coagulation parameters significantly (P<0.05). No thromboembolic complications were reported. Most of the dosing was consistent with those recommended in our institutional protocol, with discrepancies resulting in an average cost of $56 058. Moreover, pH was reported in only 67% of patients. All patients treated with rFVIIa survived up to 4 hours after receiving this agent, while the 28-day mortality was 24% (8/33).

The use of rFVIIa appears to be safe and effective in promoting hemostasis, as evident from reducing transfusion requirements and improving the coagulation variables.