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Preserved Umbilical Vein Use as Autologous Shunt Conduits in Neonatal Cardiac Surgery

NCT ID: NCT02766998

Last Updated: 2021-11-23

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

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-16

Study Completion Date

2021-11-15

Brief Summary

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This is a prospective, single center, safety and feasibility trial to evaluate the use of autologous umbilical vein as shunts or conduits in neonatal cardiac surgery. Subjects will be identified here at the Advanced Fetal Care Center (AFCC) following diagnosis of congenital heart disease (CHD) with single ventricle physiology of the fetus via fetal echocardiogram. At time of cesarean section or vaginal delivery, umbilical cord will be harvested in a sterile fashion and the umbilical vein will be dissected free and preserved until first clinically indicated Stage I palliative procedure between day 3 and 7 of life. Subjects will be followed until their Stage II palliative procedure.

Detailed Description

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Conditions

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Congenital Heart Defects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Preserved umbilical vein

Preserved umbilical vein as shunt/conduit

Group Type EXPERIMENTAL

Preserved umbilical vein as shunt/conduit

Intervention Type PROCEDURE

All subjects will have umbilical vein harvested and stored for use in first cardiac surgery requiring shunt or conduit.

Interventions

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Preserved umbilical vein as shunt/conduit

All subjects will have umbilical vein harvested and stored for use in first cardiac surgery requiring shunt or conduit.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All fetal diagnoses of complex congenital heart disease diagnosed by fetal echocardiogram requiring cardiac repair with Blalock-Taussig Shunt or Right Ventricle to Pulmonary Artery conduit will be eligible.
* This includes all pre-natal diagnoses of any single ventricle circulation physiology (SVP).
* Subjects being delivered via cesarean section or vaginally at Brigham and Women's Hospital will be considered.

Exclusion Criteria

* meconium at delivery
* symptomatic Group B Streptococcus (GBS) positive mothers
* mothers with chorioamnionitis
* Hepatitis B or C positive mothers
* HIV positive mothers.
* If unable to collect viable cord on the day of delivery of already enrolled subjects, the subject will be removed from the study on day of birth.
Minimum Eligible Age

0 Days

Maximum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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David Hoganson

Assistant in Cardiac Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sitaram Emani, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Surgeon

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-P00021450

Identifier Type: -

Identifier Source: org_study_id