NCT04616222

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Transposition of Great Vessels

Interventions

Type	Name	Description
DRUG	CELSIOR® group	Patient who received Celsior® during their transposition of the great vessels surgery according to the routine care.
DRUG	Saint-Thomas group	Patient who received Saint-Thomas during their transposition of the great vessels surgery according to the routine care.

Timeline

• Start date: 2020-09-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2020-11-04
• Last updated: 2020-11-06

Locations

1 site across 1 country: France