Use of recombinant activated factor VII for controlling refractory postoperative bleeding in children undergoing cardiac surgery with cardiopulmonary bypass.

OBJECTIVE: To review the efficacy, safety, and dose of recombinant activated factor VII in off-label management of refractory bleeding in pediatric patients with congenital heart disease undergoing cardiac surgery with cardiopulmonary bypass.
DESIGN: A retrospective database analysis with medical records review.
SETTING: A single research hospital. PARTICIPANTS: Ninety pediatric patients with uncontrolled postoperative hemorrhage after cardiac surgery with cardiopulmonary bypass for congenital heart disease.
INTERVENTIONS: Intravenous recombinant activated factor VII treatment according to institutional treatment protocol.
MEASUREMENTS AND MAIN RESULTS: The recombinant activated factor VII treatment was effective in reducing bleeding in 78 pediatric patients. The 12 patients who failed to respond had surgical sources of bleeding. The mean blood loss decreased from 51.04 mL/kg/2 h to 7.8 mL/kg/2 h (p < 0.001) in neonates, from 40.2 mL/kg/2 h to 7.7 mL/kg/2 h (p < 0.001) in infants, and from 29.1 mL/kg/2 h to 4.0 mL/kg/2 h in children (p < 0.001). The mean (standard deviation) total recombinant activated factor VII doses required to achieve hemostasis were 131.7 (69.8) μg/kg in neonates, 104.6 (36.0) μg/kg in infants, and 44.6 (15.3) μg/kg in children aged 1 to ≤18 years. There was no evidence of thrombosis in the first 24 hours after the administration of recombinant activated factor VII.
CONCLUSIONS: Recombinant activated factor VII treatment reduced blood loss and transfusion requirements and prevented re-exploration in the majority (83.8%) of pediatric cardiac surgery patients. High doses were required to discontinue bleeding promptly in neonates, the majority of whom had hypoplastic left-heart syndrome. No treatment-related thrombotic events were observed.