NCT04616222|Unknown
A Retrospective Comparison of the Efficacy and Safety of Celsior® in Pediatric Cardiac Surgery for Transposition of the Great Vessels
CELSIOR-TGV
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CELSIOR-TGV
Sponsor study identifier
observational
200
1 country
1
Study Start
September 1, 2020
Actual (reported)Primary Completion
December 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 23, 2020
Actual (reported)September 1, 2020
Actual (reported)November 4, 2020
Actual (reported)December 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Death at 30 days after surgery
Death at 30 days after surgery
30 days
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
Patient who received Celsior® during their transposition of the great vessels surgery
Patient who received Saint-Thomas during their transposition of the great vessels surgery
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.
Paediatric patients with an arterial switch operation for transposition of the great vessels
: Hôpital Louis Pradel - Service de Chirurgie Cardiaque C
Bron, 69477, France
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.
First Submitted
July 23, 2020
First Posted
November 4, 2020
Study Start
September 1, 2020
Actual (reported)Primary Completion
December 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Physical Training in Transposition of the Great Arteries
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Study Completion
December 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 6, 2020
Record last verified: 2020-07
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Source: ClinicalTrials.gov.
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