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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CELSIOR® group | Patient who received Celsior® during their transposition of the great vessels surgery |
| |
| Saint-Thomas group | Patient who received Saint-Thomas during their transposition of the great vessels surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CELSIOR® group | Drug | Patient who received Celsior® during their transposition of the great vessels surgery according to the routine care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Death at 30 days after surgery | Death at 30 days after surgery | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative troponin levels | Troponin in ng/L | 48 hours |
| Cardiac rhythm assessment | Percentage of abnormal rhythm | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Paediatric patients with an arterial switch operation for transposition of the great vessels
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julia MITCHELL, MD | Contact | 472357476 | +33 | julia.mitchell@chu-lyon.fr |
| Naoual EL JONHY | Contact | 4 72 35 69 12 | +33 | naoual.el-jonhy@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| : Hôpital Louis Pradel - Service de Chirurgie Cardiaque C | Recruiting | Bron | 69477 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39040670 | Derived | Bulescu NC, Mitchell J, Metton O, El Jonhy N, Amaz C, Perouse de Montclos T, Lilot M, Mewton N, Henaine R. Celsior(R) vs. St Thomas(R) cardioplegia: analysis of myocardial protection and clinical safety in neonates. Front Pediatr. 2024 Jul 8;12:1430832. doi: 10.3389/fped.2024.1430832. eCollection 2024. |
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| ID | Term |
|---|---|
| D014188 | Transposition of Great Vessels |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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| Saint-Thomas group | Drug | Patient who received Saint-Thomas during their transposition of the great vessels surgery according to the routine care. |
|
| Variation of pre- and post-operative creatinine levels | Creatinine in µmol/L | 24 hours |
| Intensive care unit length of stay | In days | 30 days |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |