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.
Authors
- John D. Puskas (ORCID: https://orcid.org/0000-0003-0459-4750)
- Luís Roberto Palma Dallan (ORCID: https://orcid.org/0000-0001-8137-5434)
- Fernando Faglioni Ribas (ORCID: https://orcid.org/0000-0001-7768-9289)
- Fabiane Letícia de Freitas (ORCID: https://orcid.org/0000-0002-3600-0200)
- Maurílio Onofre Deininger (ORCID: https://orcid.org/0000-0003-4588-5984)
- Rodrigo Coelho Segalote (ORCID: https://orcid.org/0000-0002-1369-0245)
- Omar Asdrúbal Vilca Mejía (ORCID: https://orcid.org/0000-0002-1635-4984)
- Luiz Augusto Ferreira Lisboa (ORCID: https://orcid.org/0000-0002-2137-0604)
- Fábio Biscegli Jatene (ORCID: https://orcid.org/0000-0001-6175-5595)
- Renato D. Lópes (ORCID: https://orcid.org/0000-0003-2999-4961)
- Alexandre Ciappina Hueb (ORCID: https://orcid.org/0000-0002-0112-8589)
- Bianca Meneghini
- Rodrigo Moreira Castro
- Francesco Consentino
- Pedro Silva (ORCID: https://orcid.org/0000-0002-6510-6135)
- M. Guerrieri (ORCID: https://orcid.org/0009-0005-8710-4316)
Institutions
- Government Medical College (IN)
- Instituto Nacional de Cardiologia (BR)
- Beneficência Portuguesa de São Paulo (BR)
- Duke Medical Center (US)
Publication Details
- Journal
- Brazilian Journal of Cardiovascular Surgery
- Published
- 2025-01-01
- DOI
- https://doi.org/10.21470/1678-9741-2025-0199
- Citations
- 1
- Primary Topic
- Cardiac and Coronary Surgery Techniques
- Type
- article
- Field-Weighted Citation Impact
- 2.01
Funders
- Fundação de Amparo à Pesquisa do Estado de São Paulo