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

Primary Purpose

Coarctation of Aorta

Status

Unknown status

Phase

Not Applicable

Locations

Russian Federation

Study Type

Interventional

Intervention

Surgical repair of coarctation of aorta

About this trial

This is an interventional treatment trial for Coarctation of Aorta focused on measuring Congenital heart disease, Coarctation of aorta, Aortic arch hypoplasia, Cerebral selective antegrade perfusion, Double arterial cannulation

Eligibility Criteria

undefined - 1 Year (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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 ejection fraction < 60%)
congenital renal or central nervous system anomalies
related infectious diseases
prematurity (gestational age < 37 weeks)

Sites / Locations

State Research Institute of CIrculation Pathology Novosibirsk, Russian FederationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Deep hypothermic arrest

Selective antegrade cerebral perfusion

Double arterial cannulation

Arm Description

Surgical repair of coarctation of aorta under deep hypothermic circulatory arrest

Surgical repair of coarctation of aorta using selective antegrade cerebral perfusion

Surgical repair of coarctation of aorta using cerebral antegrade perfusion with descending aortic cannulation

Outcomes

Primary Outcome Measures

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) )

Secondary Outcome Measures

Degree of inotropic support (inotropic score)

Intraoperative blood loss (ml)

Temperature of cooling (C)

Duration of CPB (min)

Full Information

NCT ID

NCT02835703

First Posted

July 6, 2016

Last Updated

September 5, 2018

Sponsor

Meshalkin Research Institute of Pathology of Circulation

1. Study Identification

Unique Protocol Identification Number

NCT02835703

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Unknown status

Study Start Date

July 2016 (Actual)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coarctation of Aorta

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Deep hypothermic arrest

Arm Type

Active Comparator

Arm Description

Surgical repair of coarctation of aorta under deep hypothermic circulatory arrest

Arm Title

Selective antegrade cerebral perfusion

Arm Type

Active Comparator

Arm Description

Surgical repair of coarctation of aorta using selective antegrade cerebral perfusion

Arm Title

Double arterial cannulation

Arm Type

Active Comparator

Arm Description

Surgical repair of coarctation of aorta using cerebral antegrade perfusion with descending aortic cannulation

Intervention Type

Procedure

Intervention Name(s)

Surgical repair of coarctation of aorta

Intervention Description

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

Primary Outcome Measure Information:

Title

Adverse events in early postoperative period

Description

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 Outcome Measure Information:

Title

Degree of inotropic support (inotropic score)

Time Frame

through ICU stay, an average of 3 weeks

Title

Intraoperative blood loss (ml)

Time Frame

intraoperatively

Title

Temperature of cooling (C)

Time Frame

intraoperatively

Title

Duration of CPB (min)

Time Frame

intraoperatively

10. Eligibility

Sex

All

Maximum Age & Unit of Time

1 Year

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: coarctation with severe aortic arch hypoplasia (distal aortic arch z-score < -2) coarctation of aorta with septal defects 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 ejection fraction < 60%) congenital renal or central nervous system anomalies related infectious diseases prematurity (gestational age < 37 weeks)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yuriy Y Kulyabin, MD

Phone

+79538889890

y.y.coolyabin@gmail.com

Facility Information:

Facility Name

State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation

City

Novosibirsk

ZIP/Postal Code

630055

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yuriy Y Kulyabin, MD

Phone

+79538889890

y.y.coolyabin@gmail.com

First Name & Middle Initial & Last Name & Degree

Yuriy Y Kulyabin, MD

First Name & Middle Initial & Last Name & Degree

Yuriy N Gorbatykh, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

32446921

Citation

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.

Results Reference

derived

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

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