A Pilot Study of Thrombin Generation Changes in Neonates Undergoing Placement of a Blalock-Taussig Shunt

Completed

Conditions studied: Aortic Coarctation

In brief

The primary goal of this investigation is to describe perioperative thrombin generation in neonates undergoing placement of a Blalock-Taussig (BT) shunt to better understand the coagulation changes that precipitate postoperative shunt occlusion.

Key facts

Study ID

NCT01340378

Run by

Emory University

People needed

20

Starts

2010-01-01

Expected to finish

2014-12-01

Last updated by the study team

2014-12-12

Who can join

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

You may qualify if…

• Full-term neonates (37-42 weeks gestational age)
• Apgar score of 7 or more at 5 minutes after delivery
• Surgical placement of BT shunt or repair of an aortic coarctation
• Parent or legal guardian willing to participate, and able to understand and sign the provided informed consent

You may not qualify if…

• Preterm neonates (less than 37 weeks gestation)
• Apgar score of less than 7 at 5 minutes after birth
• Emergent procedure
• Surgical procedure other than placement of BT shunt or repair of aortic coarctation
• Neonates with a known coagulation defect or coagulopathy
• Mother with a known coagulation defect or coagulopathy
• Parent or legal guardian unwilling to participate or unable to understand and sign the provided informed consent

Where it is running

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

Full record on ClinicalTrials.gov

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