Clinical Trial: A Pilot Study of Thrombin Generation Changes in Neonates Undergoing Placement of a Blalock-Taussig Shunt
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: A Pilot Study of Thrombin Generation Changes in Neonates Undergoing Placement of a Blalock-Taussig Shunt
Brief Summary: 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.
Detailed Summary: To accomplish our goal, the investigators will measure preoperative levels of one major procoagulant (prothrombin) and one major anticoagulant (Antithrombin). The investigators will also measure preoperative and postoperative thrombelastograms (TEG) and preoperative and postoperative thrombin generation curves (TGC).
Sponsor: Emory University
Current Primary Outcome: Thrombin generation - peak amount [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Thrombin Generation Curve validation in neonates [ Time Frame: 2 years ]
Original Secondary Outcome: Same as current
Information By: Emory University
Dates:
Date Received: April 12, 2011
Date Started: January 2010
Date Completion:
Last Updated: December 10, 2014
Last Verified: December 2014