Congenital Heart DefectsNCT02766998
Preserved Umbilical Vein Use as Autologous Shunt Conduits in Neonatal Cardiac Surgery
A study testing Preserved umbilical vein as shunt/conduit in people with Congenital Heart Defects, run by Boston Children's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 days to 1 day
- Conditions the study is for
- Congenital Heart Defects
- What is being tested?
- Preserved umbilical vein as shunt/conduit
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2016to 15 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
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
- Being tested
- Preserved umbilical vein as shunt/conduit
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preserved umbilical vein as shunt/conduitProcedure or surgery
All subjects will have umbilical vein harvested and stored for use in first cardiac surgery requiring shunt or conduit.
| Study group | Role | What they receive |
|---|---|---|
| Preserved umbilical vein | Experimental | Preserved umbilical vein as shunt/conduit Receives: Procedure: Preserved umbilical vein as shunt/conduit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from time of insertion to time of Stage II procedure, approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study start16 May 2016
- Primary completion15 Nov 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DefectsStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Hoganson, Boston Children's Hospital
- Investigators
- Sitaram Emani, MD, Principal investigator, Cardiovascular Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766998
- Sponsor's protocol ID
- IRB-P00021450
- Status last verified
- Nov 2021
- First submitted
- 2 May 2016
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preserved Umbilical Vein Use as Autologous Shunt Conduits in Neonatal Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02766998
- Acronym / sponsor ID
- IRB-P00021450
- Conditions
- Congenital Heart Defects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 16 May 2016 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 10 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preserved umbilical vein | Experimental | Procedure: Preserved umbilical vein as shunt/conduitPreserved umbilical vein as shunt/conduit |
Who may qualify
- Ages
- 0 days to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- meconium at delivery
- symptomatic Group B Streptococcus (GBS) positive mothers
- mothers with chorioamnionitis
- Hepatitis B or C positive mothers
- HIV positive mothers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preserved umbilical vein as shunt/conduitAll subjects will have umbilical vein harvested and stored for use in first cardiac surgery requiring shunt or conduit. | Procedure or surgery | Preserved umbilical vein |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sitaram Emani, MD principal investigator
Cardiovascular Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preserved umbilical vein as shunt/conduit in people with Congenital Heart Defects, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absense of primary serious adverse events (time frame: from time of insertion to time of Stage II procedure, approximately 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.