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

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ClinicalTrials.gov Identifier: NCT02766998
Recruitment Status : Recruiting
First Posted : May 10, 2016
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
David Hoganson, Boston Children's Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Congenital Heart Defects Procedure: Preserved umbilical vein as shunt/conduit Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preserved Umbilical Vein Use as Autologous Shunt Conduits in Neonatal Cardiac Surgery
Actual Study Start Date : May 16, 2016
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Preserved umbilical vein
Preserved umbilical vein as shunt/conduit
 Procedure: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Absense of primary serious adverse events [ Time Frame: from time of insertion to time of Stage II procedure, approximately 6 months ]

    Primary SAEs are defined as:

    • Bleeding from shunt/conduit requiring intervention (either medical or surgical)
    • Shunt/conduit thrombosis
    • Shunt/conduit infection with positive culture of preservative solution or positive clinical culture following implantation of umbilical vein
    • Aneurysm of shunt/conduit


Eligibility Criteria
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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02766998


Contacts
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Contact: Breanna Piekarski, RN, BSN 617-919-4457 breanna.piekarski@cardio.chboston.org
Contact: David Hoganson, MD david.hoganson@cardio.chboston.org

Locations
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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Breanna Piekarski, RN, BSN    617-919-4457    breanna.piekarski@cardio.chboston.org   
Sponsors and Collaborators
Boston Children's Hospital
Investigators
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Principal Investigator: Sitaram Emani, MD Cardiovascular Surgeon
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: David Hoganson, Assistant in Cardiac Surgery, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT02766998    
Other Study ID Numbers: IRB-P00021450
First Posted: May 10, 2016    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities