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

Study Overview
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Brief Summary
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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.

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

Conditions
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Transposition of Great Vessels

Intervention / Treatment
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* Drug: CELSIOR® group
* Drug: Saint-Thomas group


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CELSIOR® group<br>Patient who received Celsior® during their transposition of the great vessels surgery | Drug: CELSIOR® group<br>* Patient who received Celsior® during their transposition of the great vessels surgery according to the routine care.<br>|
| Saint-Thomas group<br>Patient who received Saint-Thomas during their transposition of the great vessels surgery | Drug: Saint-Thomas group<br>* Patient who received Saint-Thomas during their transposition of the great vessels surgery according to the routine care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death at 30 days after surgery | Death at 30 days after surgery | 30 days | 

Secondary Outcome Measures

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