Effect of Recombinant Activated Factor VII in the Management of Severe Uncontrolled Bleeding During Cardiac Surgery

Abstract

SUMMARY Recombinant activated factor VII (rFVIIa, Novo Nordisk A/S, Bagsvaerd, Denmark) is increasingly being used to secure hemostasis in difficult clinical situations. The role of rFVIIa in the treatment of patients undergoing open‐heart surgery for valvular heart disease was evaluated in an open pilot study. The study objectives were to evaluate blood loss and hemostatic effect following the administration of rFVIIa, to evaluate the safety of the treatment, and to determine its effect on laboratory parameters. To date, we have treated five patients (one child aged 2.5 years and four adults) using various surgical procedures, including arterial switch, closure of atrial septal defect and DeVega's procedure (mitral valve replacement with tricuspid valve repair). Four patients received rFVIIa intraoperatively while the fifth received it postoperatively. Satisfactory hemostasis was achieved with a single dose (30 μg/kg) of rFVIIa. Four hours after treatment with rFVIIa, the mean blood loss was 262.5 mL for adults (220–334 mL) and 85 mL for the child. No significant adverse events were seen in relation to rFVIIa therapy. The laboratory parameters indicated a mean 18.5‐fold increase (range 3.7–42) in FVII levels at 30 min post‐injection and a mean reduction of 12 s (range 3–39 s) in prothrombin time.