Prevention of Bleeding Complications in Neonates With Liver Failure Undergoing Surgery Using Recombinant Factor VIIa.

Recombinant factor Vila [rFVIIa (Novoseven®, Novo Nordisk, Bagsvaerd, Denmark)] is a novel therapy used to treat hemophiliacs with inhibitors and bleeding. Coagulopathy with severe factor VII deficiency is common in liver failure, and liver biopsies are often required in these patients; however, there is a high risk of bleeding complications. In one report, 12.5% of children with coagulopathy and 0.8% of children without coagulopathy had bleeding complications after liver biopsy. Other reports have demonstrated increased bleeding after liver biopsy in patients with bleeding disorders. Standard treatment for such patients includes fresh frozen plasma (FFP) and prothrombin complex concentrates (PCC), both of which have significant limitations. In order to achieve hemostatic factor levels, large volumes of FFP are required which may not be tolerated, especially in young children and patients with liver failure. PCC can cause DIC, especially in liver failure and carry a risk of viral transmission. We have performed liver biopsies and central venous catheter (CVC) placement in three neonates with liver failure utilizing rFVIIa to prevent bleeding complications. All three patients had mild gastrointestinal (GI) bleeding prior to surgery which did not respond to FFP and cryoprecipitate (cryo). None of the patients had bleeding complications. These cases demonstrate the utility of using rFVIIa in neonates with liver failure undergoing liver biopsy and CVC placement. Our choice of rFVIIa rather than PCC was based on selecting an agent that targets the deficiency of factor VII, concerns for disseminated intravascular coagulation, and the risk of transmitting infectious agents from plasma products. In conclusion, we recommend the use of rFVIIa for prevention of bleeding complications prior to surgery in patients with liver failure.