del Nido versus St. Thomas’ blood cardioplegia in the young (DESTINY) trial: protocol for a multicentre randomised controlled trial in children undergoing cardiac surgery
Introduction Myocardial protection against ischaemia–reperfusion injury is a key determinant of heart function and outcome following cardiac surgery in children. However, myocardial injury still occurs routinely following aortic cross-clamping, as demonstrated by the ubiquitous rise in circulating t...
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BMJ Publishing Group
2025-04-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/4/e102029.full |
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| author | Massimo Caputo Serban Stoica Kelly Handley Timothy J Jones Nigel E Drury Barnaby R Scholefield Martin Kostolny Alex Robertson Yongzhong Sun Carin Van Doorn Warwick B Dunn John V Pappachan Hugh Jarrett Carly Tooke Tina Griffin Indie Bilkhoo |
| author_facet | Massimo Caputo Serban Stoica Kelly Handley Timothy J Jones Nigel E Drury Barnaby R Scholefield Martin Kostolny Alex Robertson Yongzhong Sun Carin Van Doorn Warwick B Dunn John V Pappachan Hugh Jarrett Carly Tooke Tina Griffin Indie Bilkhoo |
| author_sort | Massimo Caputo |
| collection | DOAJ |
| description | Introduction Myocardial protection against ischaemia–reperfusion injury is a key determinant of heart function and outcome following cardiac surgery in children. However, myocardial injury still occurs routinely following aortic cross-clamping, as demonstrated by the ubiquitous rise in circulating troponin. del Nido cardioplegia was designed to protect the immature myocardium and is widely used in the USA but has not previously been available in the UK, where St. Thomas’ blood cardioplegia is most common. The del Nido versus St. Thomas’ blood cardioplegia in the young (DESTINY) trial will evaluate whether one solution is better than the other at improving myocardial protection by reducing myocardial injury, shortening ischaemic time and improving clinical outcomes.Methods and analysis The DESTINY trial is a multicentre, patient-blinded and assessor-blinded, parallel-group, individually randomised controlled trial recruiting up to 220 children undergoing surgery for congenital heart disease. Participants will be randomised in a 1:1 ratio to either del Nido cardioplegia or St. Thomas’ blood cardioplegia, with follow-up until 30 days following surgery. The primary outcome is area under the time–concentration curve for plasma high-sensitivity troponin I in the first 24 hours after aortic cross-clamp release. Secondary outcome measures include the incidence of low cardiac output syndrome and Vasoactive-Inotropic Score in the first 48 hours, total aortic cross-clamp time, duration of mechanical ventilation and lengths of stay in the paediatric intensive care unit and the hospital.Ethics and dissemination The trial was approved by the West Midlands—Coventry and Warwickshire National Health Service Research Ethics Committee (21/WM/0149) on 30 June 2021. Findings will be disseminated to the academic community through peer-reviewed publications and presentation at national and international meetings. Parents will be informed of the results through a newsletter in conjunction with a national charity.Trial registration number ISRCTN13638147; Pre-results. |
| format | Article |
| id | doaj-art-28be562d1e8a4c199afa235723a2fa06 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-28be562d1e8a4c199afa235723a2fa062025-08-20T02:26:59ZengBMJ Publishing GroupBMJ Open2044-60552025-04-0115410.1136/bmjopen-2025-102029del Nido versus St. Thomas’ blood cardioplegia in the young (DESTINY) trial: protocol for a multicentre randomised controlled trial in children undergoing cardiac surgeryMassimo Caputo0Serban Stoica1Kelly Handley2Timothy J Jones3Nigel E Drury4Barnaby R Scholefield5Martin Kostolny6Alex Robertson7Yongzhong Sun8Carin Van Doorn9Warwick B Dunn10John V Pappachan11Hugh Jarrett12Carly Tooke13Tina Griffin14Indie Bilkhoo15Bristol Heart Institute, University of Bristol, Bristol, UKDepartment of Paediatric Cardiac Surgery, Bristol Royal Hospital for Children, Bristol, UKBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, UKDepartment of Cardiovascular Sciences, University of Birmingham, Birmingham, UKDepartment of Cardiovascular Sciences, University of Birmingham, Birmingham, UKDepartment of Paediatrics, University of Toronto, Toronto, Ontario, CanadaDepartment of Paediatric Cardiac Surgery, Great Ormond Street Hospital for Children, London, UKDepartment of Paediatric Cardiac Surgery, Great Ormond Street Hospital for Children, London, UKBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, UKDepartment of Congenital Cardiac Surgery, Leeds Children’s Hospital, Leeds, UKCentre for Metabolomics Research, Biochemistry, Cell and Systems Biology, University of Liverpool, Liverpool, UKPaediatric Intensive Care, Southampton General Hospital, Southampton, UKNottingham Clinical Trials Unit, University of Nottingham, Nottingham, UKPaediatric Intensive Care, Birmingham Children’s Hospital, Birmingham, UKNottingham Clinical Trials Unit, University of Nottingham, Nottingham, UKDepartment of Paediatric Cardiac Surgery, Birmingham Children’s Hospital, Birmingham, UKIntroduction Myocardial protection against ischaemia–reperfusion injury is a key determinant of heart function and outcome following cardiac surgery in children. However, myocardial injury still occurs routinely following aortic cross-clamping, as demonstrated by the ubiquitous rise in circulating troponin. del Nido cardioplegia was designed to protect the immature myocardium and is widely used in the USA but has not previously been available in the UK, where St. Thomas’ blood cardioplegia is most common. The del Nido versus St. Thomas’ blood cardioplegia in the young (DESTINY) trial will evaluate whether one solution is better than the other at improving myocardial protection by reducing myocardial injury, shortening ischaemic time and improving clinical outcomes.Methods and analysis The DESTINY trial is a multicentre, patient-blinded and assessor-blinded, parallel-group, individually randomised controlled trial recruiting up to 220 children undergoing surgery for congenital heart disease. Participants will be randomised in a 1:1 ratio to either del Nido cardioplegia or St. Thomas’ blood cardioplegia, with follow-up until 30 days following surgery. The primary outcome is area under the time–concentration curve for plasma high-sensitivity troponin I in the first 24 hours after aortic cross-clamp release. Secondary outcome measures include the incidence of low cardiac output syndrome and Vasoactive-Inotropic Score in the first 48 hours, total aortic cross-clamp time, duration of mechanical ventilation and lengths of stay in the paediatric intensive care unit and the hospital.Ethics and dissemination The trial was approved by the West Midlands—Coventry and Warwickshire National Health Service Research Ethics Committee (21/WM/0149) on 30 June 2021. Findings will be disseminated to the academic community through peer-reviewed publications and presentation at national and international meetings. Parents will be informed of the results through a newsletter in conjunction with a national charity.Trial registration number ISRCTN13638147; Pre-results.https://bmjopen.bmj.com/content/15/4/e102029.full |
| spellingShingle | Massimo Caputo Serban Stoica Kelly Handley Timothy J Jones Nigel E Drury Barnaby R Scholefield Martin Kostolny Alex Robertson Yongzhong Sun Carin Van Doorn Warwick B Dunn John V Pappachan Hugh Jarrett Carly Tooke Tina Griffin Indie Bilkhoo del Nido versus St. Thomas’ blood cardioplegia in the young (DESTINY) trial: protocol for a multicentre randomised controlled trial in children undergoing cardiac surgery BMJ Open |
| title | del Nido versus St. Thomas’ blood cardioplegia in the young (DESTINY) trial: protocol for a multicentre randomised controlled trial in children undergoing cardiac surgery |
| title_full | del Nido versus St. Thomas’ blood cardioplegia in the young (DESTINY) trial: protocol for a multicentre randomised controlled trial in children undergoing cardiac surgery |
| title_fullStr | del Nido versus St. Thomas’ blood cardioplegia in the young (DESTINY) trial: protocol for a multicentre randomised controlled trial in children undergoing cardiac surgery |
| title_full_unstemmed | del Nido versus St. Thomas’ blood cardioplegia in the young (DESTINY) trial: protocol for a multicentre randomised controlled trial in children undergoing cardiac surgery |
| title_short | del Nido versus St. Thomas’ blood cardioplegia in the young (DESTINY) trial: protocol for a multicentre randomised controlled trial in children undergoing cardiac surgery |
| title_sort | del nido versus st thomas blood cardioplegia in the young destiny trial protocol for a multicentre randomised controlled trial in children undergoing cardiac surgery |
| url | https://bmjopen.bmj.com/content/15/4/e102029.full |
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