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

• Conditions: Transposition of Great Vessels
• Interventions: Drug: CELSIOR® group; Drug: Saint-Thomas group

• Registration Number: NCT04616222
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-23
• Study Start: 2020-09-01
• Study First Submitted QC: 2020-11-02
• Study First Posted: 2020-11-04
• Last Update Submitted: 2020-11-05
• Last Update Posted: 2020-11-06
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CELSIOR® group	CELSIOR® group	Patient who received Celsior® during their transposition of the great vessels surgery
Saint-Thomas group	Saint-Thomas group	Patient who received Saint-Thomas during their transposition of the great vessels surgery

Primary Outcome Measures

Name	Time	Method
Death at 30 days after surgery	30 days	Death at 30 days after surgery

Secondary Outcome Measures

Name	Time	Method
Post-operative troponin levels	48 hours	Troponin in ng/L
Cardiac rhythm assessment	24 hours	Percentage of abnormal rhythm
Variation of pre- and post-operative creatinine levels	24 hours	Creatinine in µmol/L
Intensive care unit length of stay	30 days	In days

Trial Locations

Locations (1)

: Hôpital Louis Pradel - Service de Chirurgie Cardiaque C; 🇫🇷 Bron, France