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A Pilot Study of Thrombin Generation Changes in Neonates Undergoing Placement of a Blalock-Taussig Shunt | Clinical Trials | Clareo Health

COMPLETED

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

NCT01340378•Emory University

View on ClinicalTrials.gov

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).

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

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

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

Locations (1)

Children's Healthcare of Atlanta at Egleston

Atlanta, Georgia, United States

Key Dates

Start Date

January 1, 2010

Primary Completion Date

January 1, 2013

Completion Date

December 1, 2014

Last Updated

December 12, 2014

Enrollment

ACTUAL participants

Conditions

Aortic Coarctation

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Pulmonary Artery StenosisAortic Coarctation

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COMPLETEDNA

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NCT06567275

Aortic Coarctation

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NOT_YET_RECRUITING

Aortic Stiffness by CMR in Aortic Coarctation

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 12, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.