A Retrospective Comparison of the Efficacy and Safety of Celsior® in Pediatric Cardiac Surgery for Transposition of the Great Vessels
CELSIOR-TGV
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedFirst Posted
Study publicly available on registry
November 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedNovember 6, 2020
July 1, 2020
3 months
July 23, 2020
November 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Death at 30 days after surgery
Death at 30 days after surgery
30 days
Secondary Outcomes (4)
Post-operative troponin levels
48 hours
Cardiac rhythm assessment
24 hours
Variation of pre- and post-operative creatinine levels
24 hours
Intensive care unit length of stay
30 days
Study Arms (2)
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
Interventions
Patient who received Celsior® during their transposition of the great vessels surgery according to the routine care.
Patient who received Saint-Thomas during their transposition of the great vessels surgery according to the routine care.
Eligibility Criteria
Paediatric patients with an arterial switch operation for transposition of the great vessels
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
: Hôpital Louis Pradel - Service de Chirurgie Cardiaque C
Bron, 69477, France
Related Publications (1)
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.
PMID: 39040670DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2020
First Posted
November 4, 2020
Study Start
September 1, 2020
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
November 6, 2020
Record last verified: 2020-07