Transposition of Great VesselsCELSIOR-TGVNCT04616222
A Retrospective Comparison of the Efficacy and Safety of Celsior® in Pediatric Cardiac Surgery for Transposition of the Great Vessels
An observational study of Transposition of Great Vessels, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Transposition of Great Vessels
- What is being tested?
- CELSIOR® group and Saint-Thomas group
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2020to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Paediatric patients with an arterial switch operation for transposition of the great vessels
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
: Hôpital Louis Pradel - Service de Chirurgie Cardiaque C
Bron, 69477
Cristian BULESCU, 4 72 11 66 24 ext. +33, nicolae-cristian.bulescu@chu-lyon.fr
About this study
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.
- Conditions
- Transposition of Great Vessels
- Being tested
- CELSIOR® group, Saint-Thomas group
- Medical subject headings
- Transposition of Great Vessels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CELSIOR® groupDrug
Patient who received Celsior® during their transposition of the great vessels surgery according to the routine care.
Saint-Thomas groupDrug
Patient who received Saint-Thomas during their transposition of the great vessels surgery according to the routine care.
| Study group | Role | What they receive |
|---|---|---|
| CELSIOR® group | Patient who received Celsior® during their transposition of the great vessels surgery Receives: Drug: CELSIOR® group | |
| Saint-Thomas group | Patient who received Saint-Thomas during their transposition of the great vessels surgery Receives: Drug: Saint-Thomas group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death at 30 days after surgery
Death at 30 days after surgery
Measured: 30 days
Secondary outcomes (4)
Post-operative troponin levels
Troponin in ng/L
Measured: 48 hours
Cardiac rhythm assessment
Percentage of abnormal rhythm
Measured: 24 hours
Variation of pre- and post-operative creatinine levels
Creatinine in µmol/L
Measured: 24 hours
Intensive care unit length of stay
In days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start1 Sep 2020
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transposition of Great VesselsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616222
- Sponsor's protocol ID
- CELSIOR-TGV_2020
- Acronym
- CELSIOR-TGV
- Status last verified
- Jul 2020
- First submitted
- 23 Jul 2020
- Last updated
- 6 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39040670
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Comparison of the Efficacy and Safety of Celsior® in Pediatric Cardiac Surgery for Transposition of the Great Vessels
- ClinicalTrials.gov ID
- NCT04616222
- Acronym / sponsor ID
- CELSIOR-TGV / CELSIOR-TGV_2020
- Conditions
- Transposition of Great Vessels
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CELSIOR® group | – | Drug: CELSIOR® groupPatient who received Celsior® during their transposition of the great vessels surgery |
| Saint-Thomas group | – | Drug: Saint-Thomas groupPatient who received Saint-Thomas during their transposition of the great vessels surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Paediatric patients with an arterial switch operation for transposition of the great vessels
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CELSIOR® groupPatient who received Celsior® during their transposition of the great vessels surgery according to the routine care. | Drug | CELSIOR® group |
| Saint-Thomas groupPatient who received Saint-Thomas during their transposition of the great vessels surgery according to the routine care. | Drug | Saint-Thomas group |
Primary outcome
Death at 30 days after surgery
Time frame: 30 days
Death at 30 days after surgery
4 secondary outcomes
Post-operative troponin levels
Time frame: 48 hours
Cardiac rhythm assessment
Time frame: 24 hours
Variation of pre- and post-operative creatinine levels
Time frame: 24 hours
Intensive care unit length of stay
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Derived from this study: PubMed 39040670Bulescu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transposition of Great Vessels, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julia MITCHELL, MD (472357476 ext. +33, julia.mitchell@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death at 30 days after surgery (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04616222, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.