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 ]

The thrombin generating capacity of plasma is measured using a fluorogenic substrate. Coagulation is initiated by contact activation and thrombin generation is monitored by a microplate fluorometer set that displays the progression of the fluorescence reaction. The peak amount of thrombin generated is expressed by absorbancy (nM).


Original Primary Outcome: Same as current

Current Secondary Outcome: Thrombin Generation Curve validation in neonates [ Time Frame: 2 years ]

The peak amount of thrombin generated as determined by the thrombin generation curve will be compared to the peak amount of thrombin generated as determined by the thromboelastogram. Both measure thrombin generation by absorbancy (nM).


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