Use of Recombinant Factor VIIa (NovoSeven) in Pediatric Cardiac Surgery

Abstract

Significant post-operative bleeding can be encountered in a small population of pediatric surgical patients requiring cardiopulmonary bypass (CPB). Recombinant factor VIIa (Novo-Seven) has been advocated as a possible off-label rescue therapy for these individuals when conventional blood component therapy alone is inadequate. This study retrospectively evaluates rFVIIa administration for the treatment of severe bleeding in pediatric patients immediately after cardiac surgical procedures requiring CPB. The records of 15 patients receiving rFVIIa for excessive rates of bleeding refractory to conventional blood component therapy were studied. Blood product utilization, rates of blood loss, and evidence of pathologic sequelae were compared with matched historical controls in retrospective fashion. NovoSeven doses ranged from 76 to 282 μg/kg (group 1 <30 kg) and 26 to 956 μg/kg (group 2 >30 kg). Blood product administration patterns were not significantly different (p > .05) in the intensive care unit (ICU) between patient groups receiving rFVIIa and those not treated. Bleeding rates (mL/kg/h) for the first 2 hours after admission to the ICU remained statistically unchanged but were significantly increased for those time periods >3 hours in patients <30 kg treated with NovoSeven. Patients >30 kg did not exhibit statistical differences in the rate of bleeding or the administration of blood products compared with matched controls. A significant reduction in prothrombin time (p = .001) and partial thromboplastin time (p = .02) was noted in patients <30 kg receiving rFVIIa. There were no pathologic sequelae directly attributed to the administration of rFVIIa in any patients treated. Trends in the improvement of bleeding disturbances were noted in the ICU in patients <30 kg treated with rFVIIa, subsequent to blood component therapy. The rate of bleeding (mL/kg/h) was improved in patients <30 kg for the first 2 hours in the ICU. For individuals >30 kg, there was no apparent benefit from the administration of rFVIIa.