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Transposition of Great VesselsNCT05160116

Influence of Timing of Switch Operation in Transposition of Great Arteries

An observational study of Transposition of Great Vessels, run by Brugmann University Hospital at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Transposition of great vessels are usually corrected by an arterial switch operation. This operation is often done during the first week of life as surgical delays lead to deconditioned left ventricle. Read more about this study

Who is it for?
Ages Up to 1 year
Conditions the study is for
Transposition of Great Vessels
How many people
151 participants
Where
1 siteBelgium
Study dates
15 Dec 2021to 10 Jun 2022
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 Up to 1 year
  • All sexes
  • No healthy volunteers
  • Child

Study population: All children with TGV operated by an arterial switch operation between 2008 and 2020.

Who may be able to join

  • Newborns with TGV and
  • operated at HUDERF between 2008 and 2020 and
  • arterial switch operation

Who cannot join

  • Any surgical technique other than the switch operation for TGV
  • patients operated before 2008

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Hôpital Universitaire des Enfants Reine Fabiola

    Brussels, 1020

Other trials in Belgium

About this study

Transposition of great vessels are usually corrected by an arterial switch operation. This operation is often done during the first week of life as surgical delays lead to deconditioned left ventricle. On the other hand early surgery carries also risks as neonatal physiology may have problems adapting to an intervention under cardiopulmonary bypass, possible pulmonary hypertension. Arterial switch operation between 2008 and 2020 done at our center will be reviewed. Primary outcome will be mortality or severe postoperative morbidity. Patients will be divided in 2 groups according to the presence or absence of the primary outcome. After propensity score matching, they will be analysed according to the timing of operation.

Read the detailed description

Scientific background and motivation

The transposition of great vessels (TGV) is a congenital heart defect in which the aorta follows the right ventricle and the pulmonary artery follows the left ventricle. At birth, the pulmonary and systemic circulations work in parallel and the communication between them depends on shunts in the cardiac stage (permeability of the Botal hole) or in the supra-cardiac (ducis arteriosus).

It's the most common congenital heart disease and his incidence is estimated between 0.7 and 0.8 per 1000 births. It's a pathology that may be associated with other heart defects, such as interventricular communication (IVC) or pulmonary stenosis, but rarely with a chromosomal abnormality or malformative syndrome.

TGV's manifestation is an isolated cyanosis, refractory to oxygen. And mortality reaches 90% in the first year of life in absence of treatment.

TGV's management has evolved over the last 50 years. First, thanks to the antenatal ultrasound diagnosis, allowing early strategies in postnatal to maintain a shunt between the two circulations (Prostaglandin and Balloon atrial septostomy). Then, by the evolution of corrective surgeries; indeed atrial repair techniques (Senning and Mustard) have given way to the arterial Switch with coronary reimplantation by microsurgery.

When it's possible, the operation takes place during the first week of life. Indeed, it's well established that surgical delay leads to a risk of left ventricle's deconditioned4 and sometimes impaired brain growth. But the risks of a premature surgery are less clear: Operability of the newborn, ability to tolerate an intervention under extracorporeal circulation (ECC), difficulties related to physiological pulmonary arterial hypertension at birth must be considered in the operative indication.

The ideal timing for surgery is still poorly defined. In 2014, Anderson et al showed better results for arterial Switches performed on the third day of life6. On the other hand, Kumar et al, also studied the relationship between operative timing and morbi/mortality of several congenital heart surgeries including the arterial Switch but they found no relationship between them.

Study design

The investigators would like to establish if there is a relationship between the age of the newborn at the time of surgery and postoperative morbi/mortality. Therefore, the investigators want to review all the medical records of children operated on a TGV by the arterial Switch technique at HUDERF between 2008 and 2020. The morbidity/mortality criteria observed will be the same as those usually used in studies conducted on paediatric cardiac surgery at HUDERF:

  1. The data of interest will be extracted from a database built up over years summing up the medical records of cardiac operated patients since 2002.
  2. Statistics:

2.1. Children will be divided into two groups according to the primary outcome (present or absent). They will be matched using a propensity analysis and then compared in terms of operating time.

2.2. The influence of operative time on the occurrence of the primary outcome will also be analysed by a linear regression technique in which the parameter "operating time" will be considered as a continuous variable.

Medical subject headings
Transposition of Great Vessels

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    death (percent) during hospitalization

    Measured: From operation until 28 days postoperatively

  2. Incidence (percent) of severe postoperative morbidity

    Severe postoperatively morbidity is defined as patients meeting at least 2 of the following events:

    • respiratory failure defined as duration of mechanical ventilation > 75th percentile of our cohort
    • prolonged inotropic support defined as duration of inotropic support > 48 hours
    • renal failure defined as glomerular filtration rate (GFR) decreased more than 75% compared to preoperative GFR

    Every patient meeting at least 2 of these 3 events will be counted as having severe postoperative morbidity.

    Total incidence (expressed as percent of total population) of severe postoperative morbidity will be recorded.

    Measured: From operation until 28 days postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2021
  2. Study start15 Dec 2021
  3. Primary completion30 Apr 2022
  4. Study completion10 Jun 2022

Resources

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
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05160116
Sponsor's protocol ID
CHUB-PED-Timing_Switch
Status last verified
Jul 2022
First submitted
9 Nov 2021
Last updated
20 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nagata H, Glick L, Lougheed J, Grattan M, Mondal T, Thakur V, Schwartz SM, Jaeggi E. Prenatal Diagnosis of Transposition of the Great Arteries Reduces Postnatal Mortality: A Population-Based Study. Can J Cardiol. 2020 Oct;36(10):1592-1597. doi: 10.1016/j.cjca.2020.01.010. Epub 2020 Jan 20.

    PubMed 32622839

  • Sidi D, Planche C, Kachaner J, Bruniaux J, Villain E, le Bidois J, Piechaud JF, Lacour-Gayet F. Anatomic correction of simple transposition of the great arteries in 50 neonates. Circulation. 1987 Feb;75(2):429-35. doi: 10.1161/01.cir.75.2.429.

    PubMed 3802447

  • Lim JM, Porayette P, Marini D, Chau V, Au-Young SH, Saini A, Ly LG, Blaser S, Shroff M, Branson HM, Sananes R, Hickey EJ, Gaynor JW, Van Arsdell G, Miller SP, Seed M. Associations Between Age at Arterial Switch Operation, Brain Growth, and Development in Infants With Transposition of the Great Arteries. Circulation. 2019 Jun 11;139(24):2728-2738. doi: 10.1161/CIRCULATIONAHA.118.037495. Epub 2019 May 28.

    PubMed 31132861

  • Anderson BR, Ciarleglio AJ, Hayes DA, Quaegebeur JM, Vincent JA, Bacha EA. Earlier arterial switch operation improves outcomes and reduces costs for neonates with transposition of the great arteries. J Am Coll Cardiol. 2014 Feb 11;63(5):481-7. doi: 10.1016/j.jacc.2013.08.1645. Epub 2013 Oct 30.

    PubMed 24184243

  • Kumar TK, Charpie JR, Ohye RG, Hirsch-Romano JC, Donohue JE, Yu S, Sood V, Wilkinson DA, Nelson K, Mitchell E, Goldberg CS, Gaies MG. Timing of neonatal cardiac surgery is not associated with perioperative outcomes. J Thorac Cardiovasc Surg. 2014 May;147(5):1573-9. doi: 10.1016/j.jtcvs.2013.07.020. Epub 2013 Aug 26.

    PubMed 23988282

  • Willems A, Datoussaid D, Tucci M, Sanchez Torres C, De Ville A, Fils JF, Van der Linden P. Impact of On-Bypass Red Blood Cell Transfusion on Severe Postoperative Morbidity or Mortality in Children. Anesth Analg. 2016 Aug;123(2):420-9. doi: 10.1213/ANE.0000000000001425.

    PubMed 27331784

Questions about this trial

What is this clinical trial studying?

An observational study of Transposition of Great Vessels, run by Brugmann University Hospital at 1 site in Belgium.

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 3 inclusion and 2 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: finished, as of the sponsor's last update on 20 Jul 2022. 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 Belgium. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: From operation until 28 days postoperatively). The study lists 2 primary outcomes in all. 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 NCT05160116, which also lists 6 linked publications.

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 20 Jul 2022.

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