A Retrospective Comparison of the Efficacy and Safety of Celsior® in Pediatric Cardiac Surgery for Transposition of the Great Vessels (CELSIOR-TGV)

Civil Hospices of Lyon

Status

Unknown

Conditions

Transposition of Great Vessels

Treatments

Drug: CELSIOR® group

Drug: Saint-Thomas group

Study type

Observational

Funder types

Other

Identifiers

NCT04616222

CELSIOR-TGV_2020

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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