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
{"title":"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。","authors":"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","doi":"10.21470/1678-9741-2025-0199","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":72457,"journal":{"name":"Brazilian journal of cardiovascular surgery","volume":"40 5","pages":"e20250199"},"PeriodicalIF":1.2000,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12306569/pdf/","citationCount":"0","resultStr":"{\"title\":\"Study Design Update of the Off-pump versus On-pump Coronary Artery Bypass Grafting in Frail Patients: FRAGILE Trial.\",\"authors\":\"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\",\"doi\":\"10.21470/1678-9741-2025-0199\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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.</p>\",\"PeriodicalId\":72457,\"journal\":{\"name\":\"Brazilian journal of cardiovascular surgery\",\"volume\":\"40 5\",\"pages\":\"e20250199\"},\"PeriodicalIF\":1.2000,\"publicationDate\":\"2025-07-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12306569/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Brazilian journal of cardiovascular surgery\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.21470/1678-9741-2025-0199\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Brazilian journal of cardiovascular surgery","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.21470/1678-9741-2025-0199","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Study Design Update of the Off-pump versus On-pump Coronary Artery Bypass Grafting in Frail Patients: FRAGILE Trial.
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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