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

Not Applicable

• Conditions: Coarctation of Aorta

• Registration Number: NCT02835703
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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)

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-06
• Study First Submitted QC: 2016-07-15
• Study First Posted: 2016-07-18
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-05
• Last Update Posted: 2018-09-07
• Primary Completion: 2018-12
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Adverse events in early postoperative period	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) )

Secondary Outcome Measures

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

Trial Locations

Locations (1)

State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation; 🇷🇺 Novosibirsk, Russian Federation