Study Design Update of the Off-pump versus On-pump Coronary Artery Bypass Grafting in Frail Patients: FRAGILE Trial.
Publication
, Journal Article
Mejia, OAV; Freitas, FLD; Meneghini, B; Deininger, MO; Segalote, R; Consentino, F; Guerrieri, M; Hueb, AC; Ribas, F; Castro, RM; Dallan, LRP ...
Published in: Braz J Cardiovasc Surg
July 29, 2025
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.
Duke Scholars
Published In
Braz J Cardiovasc Surg
DOI
EISSN
1678-9741
Publication Date
July 29, 2025
Volume
40
Issue
5
Start / End Page
e20250199
Location
Brazil
Related Subject Headings
- Treatment Outcome
- Research Design
- Randomized Controlled Trials as Topic
- Multicenter Studies as Topic
- Humans
- Frailty
- Frail Elderly
- Female
- Coronary Artery Bypass, Off-Pump
- Coronary Artery Bypass
Citation
APA
Chicago
ICMJE
MLA
NLM
Mejia, O. A. V., Freitas, F. L. D., Meneghini, B., Deininger, M. O., Segalote, R., Consentino, F., … Jatene, F. B. (2025). Study Design Update of the Off-pump versus On-pump Coronary Artery Bypass Grafting in Frail Patients: FRAGILE Trial. Braz J Cardiovasc Surg, 40(5), e20250199. https://doi.org/10.21470/1678-9741-2025-0199
Mejia, Omar Asdrubal Vilca, Fabiane Letícia de Freitas, Bianca Meneghini, Maurilio Onofre Deininger, Rodrigo Segalote, Felipe Consentino, Mauricio Guerrieri, et al. “Study Design Update of the Off-pump versus On-pump Coronary Artery Bypass Grafting in Frail Patients: FRAGILE Trial.” Braz J Cardiovasc Surg 40, no. 5 (July 29, 2025): e20250199. https://doi.org/10.21470/1678-9741-2025-0199.
Mejia OAV, Freitas FLD, Meneghini B, Deininger MO, Segalote R, Consentino F, et al. Study Design Update of the Off-pump versus On-pump Coronary Artery Bypass Grafting in Frail Patients: FRAGILE Trial. Braz J Cardiovasc Surg. 2025 Jul 29;40(5):e20250199.
Mejia, Omar Asdrubal Vilca, et al. “Study Design Update of the Off-pump versus On-pump Coronary Artery Bypass Grafting in Frail Patients: FRAGILE Trial.” Braz J Cardiovasc Surg, vol. 40, no. 5, July 2025, p. e20250199. Pubmed, doi:10.21470/1678-9741-2025-0199.
Mejia OAV, Freitas FLD, Meneghini B, Deininger MO, Segalote R, Consentino F, Guerrieri M, Hueb AC, Ribas F, Castro RM, Dallan LRP, Silva PGDBE, Lopes RD, Lisboa LAF, Puskas J, Jatene FB. Study Design Update of the Off-pump versus On-pump Coronary Artery Bypass Grafting in Frail Patients: FRAGILE Trial. Braz J Cardiovasc Surg. 2025 Jul 29;40(5):e20250199.
Published In
Braz J Cardiovasc Surg
DOI
EISSN
1678-9741
Publication Date
July 29, 2025
Volume
40
Issue
5
Start / End Page
e20250199
Location
Brazil
Related Subject Headings
- Treatment Outcome
- Research Design
- Randomized Controlled Trials as Topic
- Multicenter Studies as Topic
- Humans
- Frailty
- Frail Elderly
- Female
- Coronary Artery Bypass, Off-Pump
- Coronary Artery Bypass