Trial reportBrazilian journal of cardiovascular surgery
Off-pump versus On-pump Coronary Artery Bypass Grafting in Frail Patients: Study Protocol for the FRAGILE Multicenter Randomized Controlled Trial.
Trial report in Brazilian journal of cardiovascular surgery. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02338947 (A Multicenter, Prospective, Randomized, Clinical Trial Comparing Off-pump Versus On-pump Coronary Artery Bypass Grafting in Frail Patients), which is not on this map. Cited by 7 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicenter, Prospective, Randomized, Clinical Trial Comparing Off-pump Versus On-pump Coronary Artery Bypass Grafting in Frail Patients
Who cites it
7 citing papers in PubMed, 12 citations in OpenAlex.
- Observational
- From Exposure to Outcome: Air Pollution-Induced Oxidative Stress as a Determinant of Early and Late Outcomes After Coronary Artery Bypass Grafting.Antioxidants (Basel, Switzerland) · 2026Review
- Study Design Update of the Off-pump versus On-pump Coronary Artery Bypass Grafting in Frail Patients: FRAGILE Trial.Brazilian journal of cardiovascular surgery · 2025Article
- On- versus off-pump CABG in octogenarians: A propensity-matched analysis from the UK National Database.Journal of cardiac surgery · 2022Article
- Current Impact of Cardiopulmonary Bypass in Coronary Artery Bypass Grafting in São Paulo State.Arquivos brasileiros de cardiologia · 2020Article
- Rethinking Cognitive Impairment in the Management of Older Patients With Cardiovascular Disease.Journal of the American Heart Association · 2019Article
- The Emblematic Year of 2011, Trials and the 50 Years of Heart Transplantation: Three Relevant Issues.Brazilian journal of cardiovascular surgeryArticle
Corrections and comments
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Authors and funding
17 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionAdvances in modern medicine have led to people living longer and healthier lives. Frailty is an emerging concept in medicine yet to be explored as a risk factor in cardiac surgery. When it comes to CABG surgery, randomized controlled clinical trials have primarily focused on low-risk (ROOBY, CORONARY), elevated-risk (GOPCABE) or high-risk patients (BBS), but not on frail patients. Therefore, we believe that off-pump CABG could be an important technique in patients with limited functional capacity to respond to surgical stress. In this study, the authors introduce the new national, multicenter, randomized, controlled trial "FRAGILE", to be developed in the main cardiac surgery centers of Brazil, to clarify the potential benefit of off-pump CABG in frail patients.
methodsFRAGILE is a two-arm, parallel-group, multicentre, individually randomized (1:1) controlled trial which will enroll 630 patients with blinded outcome assessment (at 30 days, 6 months, 1 year, 2 years and 3 years), which aims to compare adverse cardiac and cerebrovascular events after off-pump versus on-pump CABG in pre-frail and frail patients. Primary outcomes will be all-cause mortality, acute myocardial infarction, cardiac arrest with successful resuscitation, low cardiac output syndrome/cardiogenic shock, stroke, and coronary reintervention. Secondary outcomes will be major adverse cardiac and cerebrovascular events, operative time, mechanical ventilation time, hyperdynamic shock, new onset of atrial fibrillation, renal replacement therapy, reoperation for bleeding, pneumonia, length of stay in intensive care unit, length of stay in hospital, number of units of blood transfused, graft patency, rate of complete revascularization, neurobehavioral outcomes after cardiac surgery, quality of life after cardiac surgery and costs. DISCUSSION: FRAGILE trial will determine whether off-pump CABG is superior to conventional on-pump CABG in the surgical treatment of pre-frail and frail patients.
trial registrationClinicalTrials.gov, ID: NCT02338947. Registered on August 29th 2014; last updated on March 21st 2016.
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