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

NCT02766998 | Completed DMC

• 1 other identifier: IRB-P00021450
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Defects

Outcome Measures

Primary Outcomes (1)

• Absense of primary serious adverse events

  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

  from time of insertion to time of Stage II procedure, approximately 6 months

Study Arms (1)

Preserved umbilical vein

EXPERIMENTAL

Preserved umbilical vein as shunt/conduit

Procedure: Preserved umbilical vein as shunt/conduit

Interventions

Preserved umbilical vein as shunt/conduit PROCEDURE

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

Preserved umbilical vein

Eligibility Criteria

• Age: 0 Days - 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Sitaram Emani, MD

  Cardiovascular Surgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant in Cardiac Surgery

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 10, 2016
• Study Start: May 16, 2016
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: November 23, 2021

Record last verified: 2021-11

Locations

US (1)