Study Design Update of the Off-pump versus On-pump Coronary Artery Bypass Grafting in Frail Patients: FRAGILE Trial.

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Brazilian journal of cardiovascular surgery Pub Date : 2025-07-29 DOI:10.21470/1678-9741-2025-0199

Omar Asdrubal Vilca Mejia, Fabiane Letícia de Freitas, Bianca Meneghini, Maurilio Onofre Deininger, Rodrigo Segalote, Felipe Consentino, Mauricio Guerrieri, Alexandre Ciappina Hueb, Fernando Ribas, Rodrigo Moreira Castro, Luís Roberto Palma Dallan, Pedro Gm de Barros E Silva, Renato D Lopes, Luiz Augusto Ferreira Lisboa, John Puskas, Fabio B Jatene

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Abstract

The Off-pump versus On-pump Coronary Artery Bypass Grafting in Frail Patients (FRAGILE Trial) is a multicenter, randomized controlled trial comparing off-pump and on-pump coronary artery bypass grafting in frail or pre-frail patients undergoing coronary artery bypass grafting. This manuscript presents an update to the FRAGILE Trial study design, detailing protocol modifications made in response to the time gap between the study's conception and its actual implementation. These changes were implemented early in the trial and were formally approved by the Ethics Committee, ensuring the scientific and ethical integrity of the study and reinforcing its relevance to address a gap in a vulnerable patient population.

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虚弱患者非体外循环与体外循环冠状动脉旁路移植术的研究设计更新：脆弱试验。

体弱患者非体外泵与非体外泵冠状动脉旁路移植术（FRAGILE Trial）是一项多中心、随机对照试验，比较体弱或体弱前患者接受冠状动脉旁路移植术的非体外泵和非体外泵冠状动脉旁路移植术。本文介绍了脆性试验研究设计的更新，详细介绍了根据研究概念和实际实施之间的时间差距所做的方案修改。这些变化在试验早期实施，并得到伦理委员会的正式批准，确保了研究的科学和伦理完整性，并加强了其与解决弱势患者群体差距的相关性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Brazilian journal of cardiovascular surgery

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