Pharmacokinetic Study of Recombinant AT III in Neonates Undergoing ECMO
Status:
Withdrawn
Trial end date:
2014-10-01
Target enrollment:
Participant gender:
Summary
Maintenance of adequate anticoagulation or blood thinning is of critical importance when
patients are placed on extracorporeal life support, such as extracorporeal membrane
oxygenation (ECMO). During ECMO, a patient's entire blood volume is constantly exposed to the
artificial surfaces of the ECMO circuit. This exposure activates the clotting cascade, and
not only is the circuit at risk for clot formation, but the patient is also at risk for
clotting within the body. Hence anticoagulation is vital in allowing the ECMO circuit to
support a patient for an extended period of time. Anticoagulation on ECMO is achieved
primarily by the use of a blood thinning agent called heparin. Heparin's main mechanism of
action is to activate an enzyme called antithrombin III (AT III). AT III deficiency has been
shown to be a common finding in pediatric patients requiring ECMO. This deficiency may then
result in ineffective blood thinning by heparin. The purpose of this study is to determine
how a neonate on ECMO, processes and eliminates a medication called ATryn® from their body.
ATryn® is a form ATIII that is made from goat's milk. This will ultimately aid in
establishing standardized dosing for the use of ATryn® in this patient population.