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

Study Overview
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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.

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)

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

Conditions
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Coarctation of Aorta

Intervention / Treatment
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* Procedure: Surgical repair of coarctation of aorta


Participation Criteria
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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)

Ages Eligible for Study
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Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Deep hypothermic arrest<br>Surgical repair of coarctation of aorta under deep hypothermic circulatory arrest | Procedure: Surgical repair of coarctation of aorta<br>* Surgical repair of coarctation of aorta with aortic arch hypoplasia under CPB<br>|
| Active Comparator: Selective antegrade cerebral perfusion<br>Surgical repair of coarctation of aorta using selective antegrade cerebral perfusion | Procedure: Surgical repair of coarctation of aorta<br>* Surgical repair of coarctation of aorta with aortic arch hypoplasia under CPB<br>|
| Active Comparator: Double arterial cannulation<br>Surgical repair of coarctation of aorta using cerebral antegrade perfusion with descending aortic cannulation | Procedure: Surgical repair of coarctation of aorta<br>* Surgical repair of coarctation of aorta with aortic arch hypoplasia under CPB<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) ) | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of inotropic support (inotropic score) |  | through ICU stay, an average of 3 weeks | 
| Intraoperative blood loss (ml) |  | intraoperatively | 
| Temperature of cooling (C) |  | intraoperatively | 
| Duration of CPB (min) |  | intraoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congenital heart disease, Coarctation of aorta, Aortic arch hypoplasia, Cerebral selective antegrade perfusion, Double arterial cannulation