An observational study in Transposition of Great Vessels, sponsored by Hospices Civils de Lyon. Status unknown at 1 site in France. Per ClinicalTrials.gov, last updated 2020-11-06.
Sponsored by Hospices Civils de Lyon · Observational
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.
45 studies on the registry are indexed under Transposition of Great Vessels; 9 are open to participants now.
This study's planned enrollment of 200 is above the median of 151 across 21 observational studies indexed under Transposition of Great Vessels.
Browse Transposition of Great Vessels studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Paediatric patients with an arterial switch operation for transposition of the great vessels
Exclusion Criteria:
Patient who received Celsior® during their transposition of the great vessels surgery
Drug: CELSIOR® group
Patient who received Saint-Thomas during their transposition of the great vessels surgery
Drug: Saint-Thomas group
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.
Death at 30 days after surgery
Death at 30 days after surgery
Time frame: 30 days
Post-operative troponin levels
Troponin in ng/L
Time frame: 48 hours
Cardiac rhythm assessment
Percentage of abnormal rhythm
Time frame: 24 hours
Variation of pre- and post-operative creatinine levels
Creatinine in µmol/L
Time frame: 24 hours
Intensive care unit length of stay
In days
Time frame: 30 days
This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Transposition of Great Vessels→
Hospices Civils de Lyon