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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02835703
Recruitment Status : Unknown
Verified September 2018 by Meshalkin Research Institute of Pathology of Circulation.
Recruitment status was:  Recruiting
First Posted : July 18, 2016
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Coarctation of Aorta Procedure: Surgical repair of coarctation of aorta Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Assessment of Perfusion Techniques During Surgical Repair of Coarctation of Aorta With Aortic Arch Hypoplasia in Infants
Actual Study Start Date : July 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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) )


Secondary Outcome Measures :
  1. Degree of inotropic support (inotropic score) [ Time Frame: through ICU stay, an average of 3 weeks ]
  2. Intraoperative blood loss (ml) [ Time Frame: intraoperatively ]
  3. Temperature of cooling (C) [ Time Frame: intraoperatively ]
  4. Duration of CPB (min) [ Time Frame: intraoperatively ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02835703


Contacts
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Contact: Yuriy Y Kulyabin, MD +79538889890 y.y.coolyabin@gmail.com

Locations
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Russian Federation
State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Yuriy Y Kulyabin, MD    +79538889890    y.y.coolyabin@gmail.com   
Principal Investigator: Yuriy Y Kulyabin, MD         
Sub-Investigator: Yuriy N Gorbatykh, MD, PhD         
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT02835703    
Other Study ID Numbers: PTAAR
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
Congenital heart disease
Coarctation of aorta
Aortic arch hypoplasia
Cerebral selective antegrade perfusion
Double arterial cannulation
Additional relevant MeSH terms:
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Aortic Coarctation
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities