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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2019-08-31

Brief Summary

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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.

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Detailed Description

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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

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Coarctation of Aorta

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Deep hypothermic arrest

Surgical repair of coarctation of aorta under deep hypothermic circulatory arrest

Group Type ACTIVE_COMPARATOR

Surgical repair of coarctation of aorta

Intervention Type PROCEDURE

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

Selective antegrade cerebral perfusion

Surgical repair of coarctation of aorta using selective antegrade cerebral perfusion

Group Type ACTIVE_COMPARATOR

Surgical repair of coarctation of aorta

Intervention Type PROCEDURE

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

Double arterial cannulation

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

Group Type ACTIVE_COMPARATOR

Surgical repair of coarctation of aorta

Intervention Type PROCEDURE

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

Interventions

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Surgical repair of coarctation of aorta

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No