TY - JOUR
T1 - Study Design Update of the Off-pump versus On-pump Coronary Artery Bypass Grafting in Frail Patients
T2 - FRAGILE Trial
AU - Mejia, Omar Asdrubal Vilca
AU - de Freitas, Fabiane Letícia
AU - Meneghini, Bianca
AU - Deininger, Maurilio Onofre
AU - Segalote, Rodrigo
AU - Consentino, Felipe
AU - Guerrieri, Mauricio
AU - Hueb, Alexandre Ciappina
AU - Ribas, Fernando
AU - Castro, Rodrigo Moreira
AU - Dallan, Luís Roberto Palma
AU - e Silva, Pedro G.M.de Barros
AU - Lopes, Renato D.
AU - Lisboa, Luiz Augusto Ferreira
AU - Puskas, John
AU - Jatene, Fabio B.
N1 - Publisher Copyright:
© 2025, Sociedade Brasileira de Cirurgia Cardiovascular. All rights reserved.
PY - 2025/9/1
Y1 - 2025/9/1
N2 - 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.
AB - 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.
KW - Coronary Artery Bypass Grafts, CABG
KW - Coronary Artery Disease
KW - Frailty Syndrome
KW - Outcomes
UR - https://www.scopus.com/pages/publications/105012649406
U2 - 10.21470/1678-9741-2025-0199
DO - 10.21470/1678-9741-2025-0199
M3 - Article
C2 - 40728943
AN - SCOPUS:105012649406
SN - 0102-7638
VL - 40
JO - Brazilian Journal of Cardiovascular Surgery
JF - Brazilian Journal of Cardiovascular Surgery
IS - 5
M1 - e20250199
ER -