Preserved Umbilical Vein Use as Autologous Shunt Conduits in Neonatal Cardiac Surgery
NCT ID: NCT02766998
Last Updated: 2021-11-23
Study Results
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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COMPLETED
NA
2 participants
INTERVENTIONAL
2016-05-16
2021-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Preserved umbilical vein
Preserved umbilical vein as shunt/conduit
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
0 Days
1 Day
ALL
No
Sponsors
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Boston Children's Hospital
OTHER
Responsible Party
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David Hoganson
Assistant in Cardiac Surgery
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
Countries
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Other Identifiers
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IRB-P00021450
Identifier Type: -
Identifier Source: org_study_id
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