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:

1. Full-term neonates (36-42 weeks gestational age)

2. Apgar score of 7 or more at 5 minutes after delivery

3. Neonates undergoing elective cardiac surgery requiring CPB at Children's Healthcare
of Atlanta at Egleston

4. Parents willing to participate, and able to understand and sign the provided informed
consent

Exclusion criteria:

1. Preterm neonates (less than 36 weeks gestation)

2. Apgar score of less than 6 at 5 minutes after birth

3. Emergent procedure

4. Patients undergoing cardiac surgery not requiring CPB

5. Neonates with a known coagulation defect or coagulopathy

6. Mother with a known coagulation defect or coagulopathy

7. Parents unwilling to participate or unable to understand and sign the provided
informed consent