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NCT02766998 · ClinicalTrials.gov registry record · NA
Preserved Umbilical Vein Use as Autologous Shunt Conduits in Neonatal Cardiac Surgery
A NA study, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 2
- Enrollment target
NCT02766998: Completed NA study, sponsored by Boston Children's Hospital.
NCT02766998 is a NA study that has completed, run by Boston Children's Hospital. The registered enrollment target is 2 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02766998, a NA study, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 2 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- PROCEDURE Preserved umbilical vein as shunt/conduit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2016-05-16 |
| Est. Completion | 2021-11-15 |
| Phase | NA |
What the finished NCT02766998 record still lists
NCT02766998 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Preserved umbilical vein as shunt/conduit is the first listed.
NCT02766998 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02766998 about?
NCT02766998 is a clinical study titled "Preserved Umbilical Vein Use as Autologous Shunt Conduits in Neonatal Cardiac Surgery". 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 ...
What is the current status of trial NCT02766998?
This trial is currently completed. It is a NA study. The enrollment target is 2 participants. The study started on 2016-05-16. Estimated completion is 2021-11-15.
What interventions are being tested in trial NCT02766998?
The interventions under investigation include: Preserved umbilical vein as shunt/conduit (PROCEDURE).
Who is sponsoring clinical trial NCT02766998?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02766998's enrollment target sits among peer trials
2 1997th of 2000 the lowest of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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