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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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).

Conditions

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Aortic Coarctation

Keywords

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neonatal surgery Blalock-Taussig shunt

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Nina Guzzetta, M.D.

Associate professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Children's Healthcare of Atlanta at Egleston

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00034496

Identifier Type: -

Identifier Source: org_study_id