NCT02835703

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 18, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

September 7, 2018

Status Verified

September 1, 2018

Enrollment Period

2.4 years

First QC Date

July 6, 2016

Last Update Submit

September 5, 2018

Conditions

Coarctation of Aorta

Keywords

Congenital heart diseaseCoarctation of aortaAortic arch hypoplasiaCerebral selective antegrade perfusionDouble arterial cannulation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

Study Arms (3)

Deep hypothermic arrest

ACTIVE COMPARATOR

Surgical repair of coarctation of aorta under deep hypothermic circulatory arrest

Procedure: Surgical repair of coarctation of aorta

Selective antegrade cerebral perfusion

ACTIVE COMPARATOR

Surgical repair of coarctation of aorta using selective antegrade cerebral perfusion

Procedure: Surgical repair of coarctation of aorta

Double arterial cannulation

ACTIVE COMPARATOR

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

Procedure: Surgical repair of coarctation of aorta

Interventions

Surgical repair of coarctation of aortaPROCEDURE

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

Deep hypothermic arrestDouble arterial cannulationSelective antegrade cerebral perfusion

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • coarctation with severe aortic arch hypoplasia (distal aortic arch z-score \< -2)
  • coarctation of aorta with septal defects

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation

Novosibirsk, 630055, Russia

RECRUITING

Related Publications (1)

  • Kulyabin YY, Bogachev-Prokophiev AV, Soynov IA, Omelchenko AY, Zubritskiy AV, Gorbatykh YN. Clinical Assessment of Perfusion Techniques During Surgical Repair of Coarctation of Aorta With Aortic Arch Hypoplasia in Neonates: A Pilot Prospective Randomized Study. Semin Thorac Cardiovasc Surg. 2020 Winter;32(4):860-871. doi: 10.1053/j.semtcvs.2020.04.015. Epub 2020 May 22.

    PMID: 32446921DERIVED

MeSH Terms

Conditions

Aortic CoarctationHeart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Yuriy Y Kulyabin, MD

CONTACT

+79538889890y.y.coolyabin@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2016

First Posted

July 18, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2018

Study Completion

August 1, 2019

Last Updated

September 7, 2018

Record last verified: 2018-09

Locations

RU(1)