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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02766998
Recruitment Status : Completed
First Posted : May 10, 2016
Last Update Posted : November 23, 2021
Sponsor:
Information provided by (Responsible Party):
David Hoganson, Boston Children's Hospital

Tracking Information
First Submitted Date  ICMJE May 2, 2016
First Posted Date  ICMJE May 10, 2016
Last Update Posted Date November 23, 2021
Actual Study Start Date  ICMJE May 16, 2016
Actual Primary Completion Date November 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preserved Umbilical Vein Use as Autologous Shunt Conduits in Neonatal Cardiac Surgery
Official Title  ICMJE Preserved Umbilical Vein Use as Autologous Shunt Conduits in Neonatal Cardiac Surgery
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Congenital Heart Defects
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Preserved umbilical vein
Preserved umbilical vein as shunt/conduit
Intervention: Procedure: Preserved umbilical vein as shunt/conduit
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 15, 2021)
2
Original Estimated Enrollment  ICMJE
 (submitted: May 6, 2016)
6
Actual Study Completion Date  ICMJE November 15, 2021
Actual Primary Completion Date November 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 0 Days to 1 Day   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02766998
Other Study ID Numbers  ICMJE IRB-P00021450
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party David Hoganson, Boston Children's Hospital
Original Responsible Party Sitaram Emani, Boston Children's Hospital, Assistant in Cardiac Surgery
Current Study Sponsor  ICMJE Boston Children's Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sitaram Emani, MD Cardiovascular Surgeon
PRS Account Boston Children's Hospital
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP