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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01340378
First Posted: April 22, 2011
Last Update Posted: December 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Children's healthcare of Atlanta: Cardiac Research Donor Funds
Information provided by (Responsible Party):
Nina Guzzetta, M.D., Emory University
  Purpose
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.

Condition
Aortic Coarctation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Pilot Study of Thrombin Generation Changes in Neonates Undergoing Placement of a Blalock-Taussig Shunt

Resource links provided by NLM:


Further study details as provided by Nina Guzzetta, M.D., Emory University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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).


Biospecimen Retention:   Samples Without DNA
Serum samples only

Enrollment: 20
Study Start Date: January 2010
Study Completion Date: December 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
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

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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01340378


Locations
United States, Georgia
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Children's healthcare of Atlanta: Cardiac Research Donor Funds
  More Information

Responsible Party: Nina Guzzetta, M.D., Associate professor of Anesthesiology, Emory University
ClinicalTrials.gov Identifier: NCT01340378     History of Changes
Other Study ID Numbers: IRB00034496
First Submitted: April 12, 2011
First Posted: April 22, 2011
Last Update Posted: December 12, 2014
Last Verified: December 2014

Keywords provided by Nina Guzzetta, M.D., Emory University:
neonatal surgery
Blalock-Taussig shunt

Additional relevant MeSH terms:
Aortic Coarctation
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Thrombin
Hemostatics
Coagulants