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

Completed

• Conditions: Aortic Coarctation

• Registration Number: NCT01340378
• Lead Sponsor: Emory University

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 Description

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2011-04-12
• Study First Submitted QC: 2011-04-21
• Study First Posted: 2011-04-22
• Primary Completion: 2013-01
• Status Verified: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-10
• Last Update Posted: 2014-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Thrombin generation - peak amount	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).

Secondary Outcome Measures

Name	Time	Method
Thrombin Generation Curve validation in neonates	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).

Trial Locations

Locations (1)

Children's Healthcare of Atlanta at Egleston; 🇺🇸 Atlanta, Georgia, United States