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

Sponsor

Emory University (Other)

Overall Status

Completed

CT.gov ID

NCT01340378

Collaborator

Children's healthcare of Atlanta: Cardiac Research Donor Funds (Other)

Enrollment

Location

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Coarctation

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).

Study Design

Study Type:

Observational

Actual Enrollment :

20 participants

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

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Dec 1, 2014

Outcome Measures

Primary Outcome Measures

Thrombin generation - peak amount [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 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 30 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nina Guzzetta, M.D., Associate professor of Anesthesiology, Emory University

ClinicalTrials.gov Identifier:

NCT01340378

Other Study ID Numbers:

IRB00034496

First Posted:

Apr 22, 2011

Last Update Posted:

Dec 12, 2014

Last Verified:

Dec 1, 2014

Keywords provided by Nina Guzzetta, M.D., Associate professor of Anesthesiology, Emory University

neonatal surgery

Blalock-Taussig shunt

Additional relevant MeSH terms:

Aortic Coarctation

Study Results

No Results Posted as of Dec 12, 2014