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

NCT ID: NCT04616222

Last Updated: 2020-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2020-12-01

Brief Summary

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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

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Conditions

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Transposition of Great Vessels

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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CELSIOR® group

Patient who received Celsior® during their transposition of the great vessels surgery

CELSIOR® group

Intervention Type DRUG

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

Saint-Thomas group

Intervention Type DRUG

Patient who received Saint-Thomas during their transposition of the great vessels surgery according to the routine care.

Interventions

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CELSIOR® group

Patient who received Celsior® during their transposition of the great vessels surgery according to the routine care.

Intervention Type DRUG

Saint-Thomas group

Patient who received Saint-Thomas during their transposition of the great vessels surgery according to the routine care.

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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: Hôpital Louis Pradel - Service de Chirurgie Cardiaque C

Bron, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Julia MITCHELL, MD

Role: CONTACT

Phone: 472357476

Email: [email protected]

Naoual EL JONHY

Role: CONTACT

Phone: 4 72 35 69 12

Email: [email protected]

Facility Contacts

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Cristian BULESCU

Role: primary

References

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Bulescu NC, Mitchell J, Metton O, El Jonhy N, Amaz C, Perouse de Montclos T, Lilot M, Mewton N, Henaine R. Celsior(R) vs. St Thomas(R) cardioplegia: analysis of myocardial protection and clinical safety in neonates. Front Pediatr. 2024 Jul 8;12:1430832. doi: 10.3389/fped.2024.1430832. eCollection 2024.

Reference Type DERIVED
PMID: 39040670 (View on PubMed)

Other Identifiers

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CELSIOR-TGV_2020

Identifier Type: -

Identifier Source: org_study_id