Thrombin Generation in Neonatal Plasma After Cardiopulmonary Bypass
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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.
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.
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Layout table for eligibility information
Ages Eligible for Study:
up to 30 Days (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Neonates (less than 30 days of age) undergoing complex congenital cardiac surgery requiring cardiopulmonary bypass
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
Preterm neonates (less than 36 weeks gestation)
Apgar score of less than 6 at 5 minutes after birth
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