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

NCT01340378 | Completed DMC

• 1 other identifier: IRB00034496
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aortic Coarctation

Keywords

neonatal surgery; Blalock-Taussig shunt

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Thrombin Generation Curve validation in neonates

  2 years

Eligibility Criteria

• Age: Up to 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• Full-term neonates (37-42 weeks gestational age)
• Apgar score of 7 or more at 5 minutes after delivery
• Surgical placement of BT shunt or repair of an aortic coarctation
• Parent or legal guardian willing to participate, and able to understand and sign the provided informed consent

You may not qualify if:

• Preterm neonates (less than 37 weeks gestation)
• Apgar score of less than 7 at 5 minutes after birth
• Emergent procedure
• Surgical procedure other than placement of BT shunt or repair of aortic coarctation
• Neonates with a known coagulation defect or coagulopathy
• Mother with a known coagulation defect or coagulopathy
• Parent or legal guardian unwilling to participate or unable to understand and sign the provided informed consent

Sponsors & Collaborators

• Emory University: lead
• Children's healthcare of Atlanta: Cardiac Research Donor Funds: collaborator

Study Sites (1)

Children's Healthcare of Atlanta at Egleston

Atlanta, Georgia, 30322, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples only

MeSH Terms

Conditions

Aortic Coarctation

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Anesthesiology

Study Record Dates

• First Submitted: April 12, 2011
• First Posted: April 22, 2011
• Study Start: January 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: December 1, 2014
• Last Updated: December 12, 2014

Record last verified: 2014-12

Locations

US (1)