Recombinant Activated Factor VIIa Treatment for Refractory Hemorrhage in Infants

OBJECTIVE: Report clinical response to recombinant factor VIIa in a cohort of critically ill infants. STUDY DESIGN: We identified all infants who received factor VIIa in the Duke Neonatal Intensive Care Unit between January 2005 and July 2008. Hematologic data and volume of blood transfusions before and after factor VIIa treatment were compared. The precipitating diagnosis for each factor VIIa use and the ensuing clinical outcomes of bleeding, thrombosis, and mortality were noted. RESULT: We identified 18 infants with median birth weight of 880 g and median gestational age of 26 weeks. One to six doses of factor VIIa (90 mcg/kg/dose) were administered, with 13 (72%) infants receiving a single dose. Hemostasis was achieved in 13 (72%) of the infants. Prothrombin time and activated partial thromboplastin time significantly decreased following treatment with factor VIIa. Volume of plasma transfusions significantly decreased following treatment with factor VIIa (p=0.02). Thrombosis occurred in 1 (11%) infant. Six (33%) infants died within 72 hours of treatment, and overall mortality was 10/18 (56%). CONCLUSION: Treatment with factor VIIa at doses of 90 mcg/kg improved coagulation studies and decreased the need for plasma transfusions in a group of critically ill infants without significant risk. Factor VIIa may be an effective addition to current treatment modalities for refractory hemorrhage in infants.