NCT05160116|Completed
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Sponsor study identifier
observational
151
1 country
1
Study Start
December 15, 2021
Actual (reported)Primary Completion
April 30, 2022
Actual (reported)Study Completion
June 10, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 10, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 9, 2021
Actual (reported)December 15, 2021
Actual (reported)December 16, 2021
Actual (reported)April 30, 2022
Actual (reported)June 10, 2022
Actual (reported)Mortality
death (percent) during hospitalization
From operation until 28 days postoperatively
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.
From operation until 28 days postoperatively
All children with TGV operated by an arterial switch operation between 2008 and 2020.
Hôpital Universitaire des Enfants Reine Fabiola
Brussels, 1020, Belgium
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.
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.
Denis Schmartz, MD
Brugmann University Hospital & HUDERF
151 participants (actual enrollment reported by the registry).
First Submitted
November 9, 2021
First Posted
December 16, 2021
Study Start
December 15, 2021
Actual (reported)Comprehensive Long-term Follow up of Adults With Arterial Switch Operation
Contact the study team to confirm eligibility.
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.
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.
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.
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.
Primary Completion
April 30, 2022
Actual (reported)Study Completion
June 10, 2022
Actual (reported)Last Updated
July 20, 2022
Record last verified: 2022-07
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