Thrombin Generation in Neonatal Plasma After Cardiopulmonary Bypass

Completed

Conditions studied: Cardiopulmonary Bypass

In brief

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.

Key facts

Study ID

NCT01352143

Run by

Emory University

People needed

24

Starts

2011-03-01

Expected to finish

2012-06-01

Last updated by the study team

2013-11-20

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Healthcare of Atlanta — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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