CeRebrUm and CardIac Protection with ALlopurinol in Neonates with Critical Congenital Heart Disease Requiring Cardiac Surgery with Cardiopulmonary Bypass (CRUCIAL): study protocol of a phase III, randomized, quadruple-blinded, placebo-controlled, Dutch multicenter trial

Raymond Stegeman, Maaike Nijman, Johannes M. P. J. Breur, Floris Groenendaal, Felix Haas, Jan B. Derks, Joppe Nijman, Ingrid M. van Beynum, Yannick J. H. J. Taverne, Ad J. J. C. Bogers, Willem A. Helbing, Willem P. de Boode, Arend F. Bos, Rolf M. F. Berger, Ryan E. Accord, Kit C. B. Roes, G. Ardine de Wit, Nicolaas J. G. Jansen, Manon J. N. L. Benders

Research output: Contribution to JournalArticleAcademicpeer-review

Original languageEnglish
Article number174
JournalTrials
Volume23
Issue number1
DOIs
Publication statusPublished - 23 Feb 2022

Funding

This study is funded by ZonMw, as part of the Goed Geneesmiddelen Gebruik, Grote Trials Ronde II program ( https://www.zonmw.nl/en/ project number 848042002), the Hartekind Foundation ( https://www.hartekind.nl ), and Friends of the Wilhelmina Children’s Hospital Foundation ( https://vriendenumcutrecht-wkz.nl ). The subsidizing parties do not play a role in the collection, analysis, and interpretation of the data; writing of the manuscripts; or decision to submit the reports for publication. We are indebted to the Dutch patient foundation ?Stichting Hartekind? (https://www.hartekind.nl) and association ?Pati?ntenvereniging Aangeboren Hartafwijkingen? (https://aangeborenhartafwijking.nl) who support this study. We thank Ace Pharmaceuticals (Zeewolde, The Netherlands) and the data managers, independent experts, data monitoring committee, and monitor for their close involvement in the study. We would also like to thank the Congenital Heart Disease LifeSpan Research group and clinical staff from the Departments of Obstetrics, Neonatology, Pediatric Cardiology, Pediatric Intensive Care, Anesthesiology, Congenital Cardiothoracic Surgery, Radiology, Child Development, Exercise and Physical Literacy, and Medical Psychology and Social Work in the participating centers. And lastly, we thank all members of the CRUCIAL trial consortium for their contributions to the study protocol and involvement in the study. CRUCIAL Trial Consortium Contributors: -ACAHA Erasmus MC Rotterdam/Radboudumc Nijmegen: Koen F. M. Joosten, Pieter C. van de Woestijne, Inge I. de Liefde, Antony van Dijk, Dafni Charisopoulou, Sinno H. P. Simons, Robin van der Lee, J?r?me M. J. Cornette, and Neeltje E. M. van Haren -UMC Groningen: Sara C. Arrigoni, Leonie K. Duin, Martin C.J. Kneyber, Elisabeth M.W. Kooi , Joost M.A.A. van der Maaten, Linda C. Meiners, Mirthe J. Mebius, and Gideon J. du Marchie Sarvaas -UMC Utrecht: Nathalie H.P. Claessens, Bram van Wijk, Paul H. Schoof, Trinette J. Steenhuis, Henriette ter Heide, Roel de Heus, Mireille N. Bekker, Roelie M. W?sten-van Asperen, Erik Koomen, Kim van Loon, and Nicole van Belle-van Haaren -Biostatistics Julius Center: Stavros Nikolakopoulos, Rene Eijkemans, and Daniela Cianci -Central Pharmacy: Arief Lalmohamed and Karin Rademaker

FundersFunder number
ACAHA Erasmus MC Rotterdam/Radboudumc Nijmegen
Arief Lalmohamed and Karin Rademaker
Dutch patient foundation ?
Gideon J. du Marchie Sarvaas
Hartekind Foundation
Nicole van Belle-van Haaren -Biostatistics Julius Center
Wilhelmina Children’s Hospital Foundation
ZonMw848042002
Universitair Medisch Centrum Utrecht

    Keywords

    • Neonate
    • Congenital heart disease
    • Allopurinol
    • Brain injury
    • Cardiac function
    • Neurodevelopmental outcome

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