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

Emory University20 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Aortic Coarctation

Eligibility

Sex: ALLMax age: 30 Days

Medical Language ↔ Plain English

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

Locations (1)

Children's Healthcare of Atlanta at Egleston

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

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).

Time frame: 2 years

Secondary Outcomes

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).

Time frame: 2 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.