Coarctation of AortaNCT02835703
Clinical Assessment of Perfusion Techniques During Repair of Coarctation With Aortic Arch Hypoplasia in Infants
A study testing Surgical repair of coarctation of aorta in people with Coarctation of Aorta, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial 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 more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Coarctation of Aorta
- What is being tested?
- Surgical repair of coarctation of aorta
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteRussia
- Study dates
- Jul 2016to Aug 2019
- 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 Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- coarctation with severe aortic arch hypoplasia (distal aortic arch z-score < -2)
- coarctation of aorta with septal defects
Who cannot join
- 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 ejection fraction < 60%)
- congenital renal or central nervous system anomalies
- related infectious diseases
- prematurity (gestational age < 37 weeks)
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
Novosibirsk, 630055
Yuriy Y Kulyabin, MD, +79538889890, y.y.coolyabin@gmail.com
Yuriy Y Kulyabin, MD
About this study
Official title: Clinical Assessment of Perfusion Techniques During Surgical Repair of Coarctation of Aorta With Aortic Arch Hypoplasia in Infants
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
- Coarctation of Aorta
- Being tested
- Surgical repair of coarctation of aorta
- Keywords
- Congenital heart disease, Coarctation of aorta, Aortic arch hypoplasia, Cerebral selective antegrade perfusion, Double arterial cannulation
- Medical subject headings
- Aortic Coarctation, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical repair of coarctation of aortaProcedure or surgery
Surgical repair of coarctation of aorta with aortic arch hypoplasia under CPB
| Study group | Role | What they receive |
|---|---|---|
| Deep hypothermic arrest | Active comparator | Surgical repair of coarctation of aorta under deep hypothermic circulatory arrest Receives: Procedure: Surgical repair of coarctation of aorta |
| Selective antegrade cerebral perfusion | Active comparator | Surgical repair of coarctation of aorta using selective antegrade cerebral perfusion Receives: Procedure: Surgical repair of coarctation of aorta |
| Double arterial cannulation | Active comparator | Surgical repair of coarctation of aorta using cerebral antegrade perfusion with descending aortic cannulation Receives: Procedure: Surgical repair of coarctation of aorta |
What is being measured
The primary outcome is the main question the study is designed to answer.
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) )
Measured: 30 days after surgery
Secondary outcomes (4)
Degree of inotropic support (inotropic score)
Measured: through ICU stay, an average of 3 weeks
Intraoperative blood loss (ml)
Measured: intraoperatively
Temperature of cooling (C)
Measured: intraoperatively
Duration of CPB (min)
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2018 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coarctation of AortaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835703
- Sponsor's protocol ID
- PTAAR
- Status last verified
- Sep 2018
- First submitted
- 6 Jul 2016
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Perfusion Techniques During Surgical Repair of Coarctation of Aorta With Aortic Arch Hypoplasia in Infants
- ClinicalTrials.gov ID
- NCT02835703
- Acronym / sponsor ID
- PTAAR
- Conditions
- Coarctation of Aorta
- Keywords
- Congenital heart disease, Coarctation of aorta, Aortic arch hypoplasia, Cerebral selective antegrade perfusion, Double arterial cannulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 18 Jul 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.
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.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Deep hypothermic arrest | Active comparator | Procedure: Surgical repair of coarctation of aortaSurgical repair of coarctation of aorta under deep hypothermic circulatory arrest |
| Selective antegrade cerebral perfusion | Active comparator | Procedure: Surgical repair of coarctation of aortaSurgical repair of coarctation of aorta using selective antegrade cerebral perfusion |
| Double arterial cannulation | Active comparator | Procedure: Surgical repair of coarctation of aortaSurgical repair of coarctation of aorta using cerebral antegrade perfusion with descending aortic cannulation |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- coarctation with severe aortic arch hypoplasia (distal aortic arch z-score < -2)
- coarctation of aorta with septal defects
Key exclusion criteria (8 listed)
- 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 ejection fraction < 60%)
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 |
|---|---|---|
| Surgical repair of coarctation of aortaSurgical repair of coarctation of aorta with aortic arch hypoplasia under CPB | Procedure or surgery | Deep hypothermic arrest, Double arterial cannulation, Selective antegrade cerebral perfusion |
Primary outcome
Adverse events in early postoperative period
Time frame: 30 days after surgery
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) )
4 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Derived from this study: PubMed 32446921Kulyabin 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.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical repair of coarctation of aorta in people with Coarctation of Aorta, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 7 Sep 2018. 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 Russia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuriy Y Kulyabin, MD (+79538889890, y.y.coolyabin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events in early postoperative period (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02835703, which also lists 1 linked publication.
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 7 Sep 2018.