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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Children's healthcare of Atlanta: Cardiac Research Donor Funds
Information provided by (Responsible Party):
Nina Guzzetta, M.D., Emory University
ClinicalTrials.gov Identifier:
NCT01340378
First received: April 12, 2011
Last updated: November 19, 2013
Last verified: November 2013
  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 Emory University:

Primary Outcome Measures:
  • Thrombin generation - peak amount [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Estimated Study Completion Date: January 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

Ages Eligible for Study:   up to 30 Days
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Nina Guzzetta, M.D., Associate professor of Anesthesiology, Emory University
ClinicalTrials.gov Identifier: NCT01340378     History of Changes
Other Study ID Numbers: IRB00034496
Study First Received: April 12, 2011
Last Updated: November 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
neonatal surgery
Blalock-Taussig shunt

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

ClinicalTrials.gov processed this record on July 22, 2014