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

September 5, 2018 updated by: Meshalkin Research Institute of Pathology of Circulation

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Novosibirsk, Russian Federation, 630055
        • Recruiting
        • State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
        • Contact:
        • Principal Investigator:
          • Yuriy Y Kulyabin, MD
        • Sub-Investigator:
          • Yuriy N Gorbatykh, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events in early postoperative period
Time Frame: 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) )
30 days after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

July 6, 2016

First Submitted That Met QC Criteria

July 15, 2016

First Posted (Estimate)

July 18, 2016

Study Record Updates

Last Update Posted (Actual)

September 7, 2018

Last Update Submitted That Met QC Criteria

September 5, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTAAR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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