OBJECTIVE: To examine off-label recombinant factor VIIa (rFVIIa) use in pediatric patients including clinical indications, dose, adverse events, and outcomes. METHODS: All pediatric patients entered into the Haemostasis Registry from 75 participating hospitals were analyzed. RESULTS: Three hundred and eighty-eight pediatric patients received off-label rFVIIa from 2003 to 2009. Median age was 12 months (interquartile range 1 month to 11 years). Clinical context included cardiac surgery (52.1 ), medical (11.6 ), other surgery (10.8 ), hematology/oncology (10.3 ), trauma (9.3 ), intracranial hemorrhage (3.1 ), and liver disease (2.8 ). Twenty-six patients received extracorporeal membrane oxygenation at the time of rFVIIa administration. Median first dose was 114 ?g/kg (interquartile range 90-181; range 7-2250). Thirty-four percent received >1 dose. There was a reduction in usage of red blood cells, platelets, fresh-frozen plasma, and cryoprecipitate in the 24 hours after the first dose for all patients (all P values <.001). Thromboembolic adverse events (TEAs) were reported in 5.4 . No association between TEA and size of first dose was found. Where data were available, 82 of patients were subjectively classified as responding to rFVIIa. Overall 28-day mortality was 27 . In multivariate analysis, pH values before administration and clinical context were independently associated with response to first dose and 28-day mortality. CONCLUSIONS: There was a significant reduction in blood product administration after rFVIIa and a subjective response rate of 82 . Both pH and clinical context were associated with response to rFVIIa and mortality. Overall, 5.4 had a TEA reported.