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

Sponsor
Boston Children's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02766998
Collaborator
(none)
2
Enrollment
1
Location
1
Arm
66
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Preserved umbilical vein as shunt/conduit
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
2 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
Actual Primary Completion Date :
Nov 15, 2021
Actual Study Completion Date :
Nov 15, 2021

Arms and Interventions

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

Primary Outcome Measures

  1. Absense of primary serious adverse events [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

Criteria

Ages Eligible for Study:
0 Days to 1 Day
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Boston Children's Hospital Boston Massachusetts United States 02115

Sponsors and Collaborators

  • Boston Children's Hospital

Investigators

  • Principal Investigator: Sitaram Emani, MD, Cardiovascular Surgeon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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
Last Update Posted:
Nov 23, 2021
Last Verified:
Nov 1, 2021
Additional relevant MeSH terms:
Heart Defects, Congenital

Study Results

No Results Posted as of Nov 23, 2021