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

Transposition of Great Vessels Clinical Trial

— CELSIOR-TGV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04616222
• Other study ID #: CELSIOR-TGV_2020
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: July 2020
• Source: Hospices Civils de Lyon
• Contact: Julia MITCHELL, MD
• Phone: 472357476
• Email: julia.mitchell[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Situs Inversus
• Transposition of Great Vessels

Intervention

Drug:
• CELSIOR® group
Patient who received Celsior® during their transposition of the great vessels surgery according to the routine care.
• Saint-Thomas group
Patient who received Saint-Thomas during their transposition of the great vessels surgery according to the routine care.

Locations

Country	Name	City	State
France	: Hôpital Louis Pradel - Service de Chirurgie Cardiaque C	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death at 30 days after surgery	Death at 30 days after surgery	30 days
Secondary	Post-operative troponin levels	Troponin in ng/L	48 hours
Secondary	Cardiac rhythm assessment	Percentage of abnormal rhythm	24 hours
Secondary	Variation of pre- and post-operative creatinine levels	Creatinine in µmol/L	24 hours
Secondary	Intensive care unit length of stay	In days	30 days