Thrombin Generation in Neonatal Plasma After Cardiopulmonary Bypass

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary goal of this investigation is to determine the ability of recombinant activated factor VII (rFVIIa) and prothrombin complex concentrate (PCC) to improve thrombin generation in neonatal plasma after CPB.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: Children's Research Oversight Committee Funds
• Treatments: Thrombin

Criteria

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