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

Coarctation of Aorta Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02835703
• Other study ID #: PTAAR
• Status: Recruiting
• Phase: N/A
• Start date: July 2016
• Est. completion date: August 2019

Study information

• Verified date: September 2018
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Yuriy Y Kulyabin, MD
• Phone: +79538889890
• Email: y.y.coolyabin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: August 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Year

Eligibility

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)

Related Conditions & MeSH terms

• Aortic Coarctation
• Coarctation of Aorta

Intervention

Procedure:
• Surgical repair of coarctation of aorta
Surgical repair of coarctation of aorta with aortic arch hypoplasia under CPB

Locations

Country	Name	City	State
Russian Federation	State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Degree of inotropic support (inotropic score)		through ICU stay, an average of 3 weeks
Secondary	Intraoperative blood loss (ml)		intraoperatively
Secondary	Temperature of cooling (C)		intraoperatively
Secondary	Duration of CPB (min)		intraoperatively