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

December 10, 2014 updated by: Nina Guzzetta, M.D., Emory University
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.

Study Overview

Status

Completed

Conditions

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).

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Children's Healthcare of Atlanta at Egleston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

Children's healthcare of Atlanta: Cardiac Research Donor Funds

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 12, 2011

First Submitted That Met QC Criteria

April 21, 2011

First Posted (Estimate)

April 22, 2011

Study Record Updates

Last Update Posted (Estimate)

December 12, 2014

Last Update Submitted That Met QC Criteria

December 10, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00034496

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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