A Retrospective Comparison of the Efficacy and Safety of Celsior® in Pediatric Cardiac Surgery for Transposition of the Great Vessels

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Brief Title

A Retrospective Comparison of the Efficacy and Safety of Celsior® in Pediatric Cardiac Surgery for Transposition of the Great Vessels

Official Title

A Retrospective Comparison of the Efficacy and Safety of Celsior® in Pediatric Cardiac Surgery for Transposition of the Great Vessels

Brief Summary

      Celsior® is an organ preservation solution used for the harvesting and the preservation of
      solid organs. Its use as a crystalloid cardioplegia solution has been established recently.
      Its main advantage is the long duration of myocardial protection. Compared to the other
      cardioplegia solutions, it allows a reduced amount of solution administered during the
      surgery and fewer interruptions during the intervention for the administration of
      supplemental doses of cardioplegia for long and complex operations.

      The objective of this register is to compare the safety and the efficacy of Celsior® to the
      old cardioplegia solution Saint-Thomas used as cardioplegia solution in surgery of the
      transposition of great vessels, the arterial switch operation.
    



Study Type

Observational


Primary Outcome

Death at 30 days after surgery

Secondary Outcome

 Post-operative troponin levels

Condition

Transposition of Great Vessels

Intervention

CELSIOR® group

Study Arms / Comparison Groups

 CELSIOR® group
Description:  Patient who received Celsior® during their transposition of the great vessels surgery

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

200

Start Date

September 1, 2020

Completion Date

December 1, 2020

Primary Completion Date

December 1, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Patient of neonatal age at the time of the intervention

          -  Patients with a transposition of the great vessels with intact septum and with the
             arterial switch operation performed as a corrective procedure

          -  CELSIOR® used as cardioplegia solution between 2012 and 2019

          -  Saint-Thomas used as cardioplegia solution (control group) between 2005 and 2011

        Exclusion Criteria:

          -  Major cardiovascular malformations needing correction during the surgery for the
             transposition of great vessels including : interventricular communication, coarctation
             of the aorta, interruption of the aortic arch

          -  Significant anomalies of coronary arteries origin or paths including : intramural
             course, single coronary ostium

          -  Opposition to participate in this retrospective research
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

, 472357476, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT04616222

Organization ID

CELSIOR-TGV_2020


Responsible Party

Sponsor

Study Sponsor

Hospices Civils de Lyon


Study Sponsor

, , 


Verification Date

July 2020