Thrombin Generation in Neonatal Plasma After Cardiopulmonary Bypass

In this investigation, the investigators propose a comparison in vitro of the ability of rFVIIa with that of PCC to increase thrombin generation in neonatal plasma after CPB. A pre-cardiopulmonary bypass (CPB) baseline blood sample will be obtained. After the termination of CPB and the administration of one round of protamine, platelets and fibrinogen (standard of care), a second blood sample will be drawn. All samples will be centrifuged to yield platelet rich plasma and stored until processing. In the pre-CPB sample, baseline thrombin generation will be measured. The post-CPB sample will be divided into three aliquots to measure thrombin generation under three different circumstances: the first will serve as a control, the second will include rFVIIa and the third PCC.

Inclusion criteria

• Full-term neonates (36-42 weeks gestational age)
• Apgar score of 7 or more at 5 minutes after delivery
• Neonates undergoing elective cardiac surgery requiring CPB at Children's Healthcare of Atlanta at Egleston
• Parents willing to participate, and able to understand and sign the provided informed consent

Exclusion criteria

• Preterm neonates (less than 36 weeks gestation)
• Apgar score of less than 6 at 5 minutes after birth
• Emergent procedure
• Patients undergoing cardiac surgery not requiring CPB
• Neonates with a known coagulation defect or coagulopathy
• Mother with a known coagulation defect or coagulopathy
• Parents unwilling to participate or unable to understand and sign the provided informed consent