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

Aortic Coarctation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01340378
• Other study ID #: IRB00034496
• Status: Completed
• Phase: N/A
• First received: April 12, 2011
• Last updated: December 10, 2014
• Start date: January 2010
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Days

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Coarctation

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta at Egleston	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Children's healthcare of Atlanta: Cardiac Research Donor Funds

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thrombin generation - peak amount	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	No
Secondary	Thrombin Generation Curve validation in neonates	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	No