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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01340378

Enrollment

Registered

2011-04-22

Start date

2010-01-31

Completion date

2014-12-31

Last updated

2014-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Coarctation

Keywords

neonatal surgery, Blalock-Taussig shunt

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.

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).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 30 Days

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

United States

Outcome results