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History of Changes for Study: NCT02766998
Preserved Umbilical Vein Use as Autologous Shunt Conduits in Neonatal Cardiac Surgery
Latest version (submitted November 15, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 6, 2016 None (earliest Version on record)
2 December 1, 2016 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 January 22, 2018 Study Status and Sponsor/Collaborators
4 January 29, 2019 Study Status
5 August 4, 2020 Study Status
6 November 15, 2021 Recruitment Status, Study Status, Contacts/Locations, Study Design and Eligibility
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Study NCT02766998
Submitted Date:  May 6, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: IRB-P00021450
Brief Title: Preserved Umbilical Vein Use as Autologous Shunt Conduits in Neonatal Cardiac Surgery
Official Title: Preserved Umbilical Vein Use as Autologous Shunt Conduits in Neonatal Cardiac Surgery
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2016
Overall Status: Not yet recruiting
Study Start: June 2016
Primary Completion: June 2018 [Anticipated]
Study Completion:
First Submitted: May 2, 2016
First Submitted that
Met QC Criteria:
May 6, 2016
First Posted: May 10, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
May 6, 2016
Last Update Posted: May 10, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Boston Children's Hospital
Responsible Party: Principal Investigator
Investigator: Sitaram Emani
Official Title: Assistant in Cardiac Surgery
Affiliation: Boston Children's Hospital
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Congenital Heart Defects
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 6 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age:
Maximum Age: 1 Day
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Breanna Piekarski, RN, BSN
Telephone: 617-919-4457
Email: breanna.piekarski@cardio.chboston.org
Central Contact Backup: David Hoganson, MD
Email: david.hoganson@cardio.chboston.org
Study Officials: Sitaram Emani, MD
Principal Investigator
Cardiovascular Surgeon
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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