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Completed

NCT Number: NCT01340378

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

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.

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Key information

Conditions

Aortic Coarctation Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

Up to 30 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Healthcare of Atlanta at Egleston

Atlanta, Georgia, 30322, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Children's healthcare of Atlanta: Cardiac Research Donor Funds

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Apr 22, 2011
Registry last updated
Dec 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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