A Retrospective Comparison of the Efficacy and Safety of Celsior® in Pediatric Cardiac Surgery for Transposition of the Great Vessels (CELSIOR-TGV)

November 5, 2020 updated by: Hospices Civils de Lyon

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

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

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Paediatric patients with an arterial switch operation for transposition of the great vessels

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CELSIOR® group
Patient who received Celsior® during their transposition of the great vessels surgery
Drug: CELSIOR® group
Patient who received Celsior® during their transposition of the great vessels surgery according to the routine care.
Saint-Thomas group
Patient who received Saint-Thomas during their transposition of the great vessels surgery
Drug: Saint-Thomas group
Patient who received Saint-Thomas during their transposition of the great vessels surgery according to the routine care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death at 30 days after surgery
Time Frame: 30 days
Death at 30 days after surgery
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative troponin levels
Time Frame: 48 hours
Troponin in ng/L
48 hours
Cardiac rhythm assessment
Time Frame: 24 hours
Percentage of abnormal rhythm
24 hours
Variation of pre- and post-operative creatinine levels
Time Frame: 24 hours
Creatinine in µmol/L
24 hours
Intensive care unit length of stay
Time Frame: 30 days
In days
30 days

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

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)

September 1, 2020

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

July 23, 2020

First Submitted That Met QC Criteria

November 2, 2020

First Posted (Actual)

November 4, 2020

Study Record Updates

Last Update Posted (Actual)

November 6, 2020

Last Update Submitted That Met QC Criteria

November 5, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CELSIOR-TGV_2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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