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

April 12, 2011
November 19, 2013
January 2010
January 2013   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01340378 on ClinicalTrials.gov Archive Site
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).
Same as current
Not Provided
Not Provided
 
A Pilot Study of Thrombin Generation Changes in Neonates Undergoing Placement of a Blalock-Taussig Shunt
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.

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).

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Serum samples only

Non-Probability Sample
  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
Aortic Coarctation
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
January 2014
January 2013   (final data collection date for primary outcome measure)

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
Both
up to 30 Days
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01340378
IRB00034496
Yes
Nina Guzzetta, M.D., Emory University
Emory University
Children's healthcare of Atlanta: Cardiac Research Donor Funds
Not Provided
Emory University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP