Status unknownNCT02835703Updated Sep 7, 2018

Clinical Assessment of Perfusion Techniques During Repair of Coarctation With Aortic Arch Hypoplasia in Infants

An interventional study of Surgical repair of coarctation of aorta in Coarctation of Aorta, sponsored by Meshalkin Research Institute of Pathology of Circulation. Status unknown at 1 site in Russian Federation. Open to participants aged Up to 1 Year. Per ClinicalTrials.gov, last updated 2018-09-07.

Sponsored by Meshalkin Research Institute of Pathology of Circulation · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 45
Allocation: Randomized
Ages: Up to 1 Year
Sex: All

Study summary

The purpose of this study is to evaluate safety and efficacy of three main perfusion methods in surgical repair of coarctation of aorta with aortic arch hypoplasia in infants.

Read the detailed description

Three perfusion techniques of visceral protection will be assessed - deep hypothermic circulatory arrest, selective antegrade cerebral perfusion and double arterial cannulation (perfusion of brachiocephalic artery with thoracic descending aorta by two arterial cannulas)

Conditions studied

Coarctation of Aorta

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Keywords

Congenital heart disease
Coarctation of aorta
Aortic arch hypoplasia
Cerebral selective antegrade perfusion
Double arterial cannulation

In context

Aortic Coarctation

49 studies on the registry are indexed under Aortic Coarctation; 16 are open to participants now.

This study's planned enrollment of 45 is close to the median of 45 across 19 interventional studies indexed under Aortic Coarctation.

Browse Aortic Coarctation studies →

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation is the lead sponsor of 119 studies on the registry; 9 are open to participants now.

Browse Meshalkin Research Institute of Pathology of Circulation studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Up to 1 Year
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

coarctation with severe aortic arch hypoplasia (distal aortic arch z-score \< -2)
coarctation of aorta with septal defects

Exclusion criteria

Exclusion Criteria:

coarctation with mild aortic arch hypoplasia (distal aortic arch z-score > -2)
complex congenital heart diseases including aortic arch hypoplasia (e.g. transposition of great arteries, double oulet right ventricle, atrioventricular septal defect, Shone's complex)
univentricular and duct-dependent heart defects
aortic valve and/or mitral valve stenosis/hypoplasia (aortic valve or mitral valve z-score \< -2.0)
left ventricular dysfunction (left ventricle \< 60%)
congenital renal or central nervous system anomalies
related infectious diseases
prematurity (gestational age \< 37 weeks)

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction): The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 45 participants (estimated)

Study arms

Active comparator
Deep hypothermic arrest
Surgical repair of coarctation of aorta under deep hypothermic circulatory arrest
Procedure: Surgical repair of coarctation of aorta
Active comparator
Selective antegrade cerebral perfusion
Surgical repair of coarctation of aorta using selective antegrade cerebral perfusion
Procedure: Surgical repair of coarctation of aorta
Active comparator
Double arterial cannulation
Surgical repair of coarctation of aorta using cerebral antegrade perfusion with descending aortic cannulation
Procedure: Surgical repair of coarctation of aorta

Interventions

ProcedureSurgical repair of coarctation of aorta
Surgical repair of coarctation of aorta with aortic arch hypoplasia under CPB

What researchers measure

Primary outcomes

Adverse events in early postoperative period
Number of participants with adverse events that are related to treatment (including hospital mortality, renal injury (pRIFLE criteria), neurological complications (confirmed by CT or MRI) )
Time frame: 30 days after surgery

Secondary outcomes

Degree of inotropic support (inotropic score)
Time frame: through ICU stay, an average of 3 weeks
Intraoperative blood loss (ml)
Time frame: intraoperatively
Temperature of cooling (C)
Time frame: intraoperatively
Duration of CPB (min)
Time frame: intraoperatively

Study locations

1 of 1 sites recruiting

State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
Novosibirsk, 630055, Russian Federation
Recruiting
- Yuriy Y Kulyabin, MD · Contact · y.y.coolyabin@gmail.com · +79538889890
- Yuriy Y Kulyabin, MD · Principal investigator
- Yuriy N Gorbatykh, MD, PhD · Sub investigator
Recruiting

References and documents

Publications

Kulyabin YY, Bogachev-Prokophiev AV, Soynov IA, Omelchenko AY, Zubritskiy AV, Gorbatykh YN. Clinical Assessment of Perfusion Techniques During Surgical Repair of Coarctation of Aorta With Aortic Arch Hypoplasia in Neonates: A Pilot Prospective Randomized Study. Semin Thorac Cardiovasc Surg. 2020 Winter;32(4):860-871. doi: 10.1053/j.semtcvs.2020.04.015. Epub 2020 May 22. PubMed 32446921 ↗

Individual participant data

Plan to share: Undecided

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Started Jul 2016 (actual). Primary completion is estimated for Dec 2018, 29 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered: Jul 6, 2016
First posted: Jul 18, 2016
StartActual: Jul 2016
Primary completionEst.: Dec 2018
CompletionEst.: Aug 2019
Last update: Sep 7, 2018

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Sep 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02835703
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Responsible party: Sponsor
First posted: Jul 18, 2016
Start date: Jul 2016
Primary completion: Dec 2018 (estimated)
Completion: Aug 2019 (estimated)
Last update: Sep 7, 2018

Study contacts

Yuriy Y Kulyabin, MD

Contact

y.y.coolyabin@gmail.com

+79538889890

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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