Pharmacokinetic Study of Recombinant AT III in Neonates Undergoing ECMO

• Status: Withdrawn
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Los Angeles
• Treatments: Antithrombin III; Antithrombins

Criteria

Inclusion Criteria:

• Neonates requiring ECMO

• Must be < or = to 30 days of age

• Must be > or = to 37weeks corrected gestational age

Exclusion Criteria:

• Older than or = to 31 days of age

• Preterm neonates < 37weeks corrected gestational age

• Previously diagnosed hereditary coagulopathy or hemorrhagic disorder in the family

• Prior to recent anticoagulation use

• Known or suspected genetic or terminal disorder

• Known family history of hypersensitivity to goat's milk or goat milk products