ERASREPLICCARIIINCT06786819
Impact of a Technology Platform Based on Enhanced Recovery After(ERAS) Surgery on Length of Stay After Coronary Artery Bypass Grafting: Timely Project
A study testing ERACS with Digital Platform in people with ERAS and Cardiac Surgery, run by University of Sao Paulo General Hospital at 2 sites in Brazil.
Trial summary
Cardiovascular diseases continue to be the leading cause of death worldwide. Among them, coronary artery disease has the greatest impact, being characterized as one of the main causes of death in Brazil over the last decade. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ERAS, Cardiac Surgery, Cardiac Surgery-CABG
- What is being tested?
- ERACS with Digital Platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 2 sitesBrazil
- Study dates
- 10 Mar 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 18 years old
- Indication for primary isolated CABG (elective or urgent status)
- Own a personal cell phone
- Have internet access
- Knowledgeable in using the device
- Full understanding and agreement regarding the informed consent form (ICF)
Who cannot join
- Indication for associated surgery
- Glycosylated hemoglobin level greater than 8%
- Creatinine clearance less than 30 mL/min
- Pre-operative atrial fibrillation or use of pre-operative anticoagulation
- Hemoglobin less than 12 g/dL
- Users of illicit drugs
Show all 9Show fewer
- STS score greater than 4%
- Physical or mental disabilities that prevent adherence to the protocol
- Refusal by the patient or family member
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil2 sites, 2 recruiting
- Recruiting
InCor - Instituto do Coração do Hospital das Clínicas da FMUSP
São Paulo, São Paulo, 05403-900
- Recruiting
InCor - Instituto do Coração do Hospital das Clínicas da FMUSP
São Paulo, São Paulo, 05403-900
Omar AV Mejia, MD, PhD, +551126615014, omarvmejia@gmail.com
Gabrielle B Borgomoni, BSc, +551126615014, gabrielle.barbosa@hc.fm.usp.br
About this study
Official title: Estudo Randomizado de Cluster Escalonado Para Avaliar o Impacto de Uma Plataforma tecnológica Baseada no ERAS (Enhanced Recovery After Surgery) no Tempo de permanência após Cirurgia de revascularização miocárdica: Projeto Tempos Certos - REPLICCAR III
Cardiovascular diseases continue to be the leading cause of death worldwide. Among them, coronary artery disease has the greatest impact, being characterized as one of the main causes of death in Brazil over the last decade. One of the well-established treatments is coronary artery bypass grafting, which is the most performed among cardiac surgeries and, in our scenario, is primarily funded by the Unified Health System (SUS). The information obtained from the Paulista Registry of Cardiovascular Surgeries (REPLICCAR), in partnership with FAPESP, has been important for implementing improvements in the landscape of cardiac surgeries in the state of São Paulo. Although outcomes in cardiac surgery have improved due to the structuring and organization of quality programs, this is still not a reality at the national level. In a situation where data collection and quality initiatives play a central role in continuous improvement, generating value becomes essential for the sustainability of cardiac surgery programs. In this sense, the concept of Enhanced Recovery After Surgery (ERAS) has gained increasing traction. This concept is based on multidisciplinary protocols and scientific evidence, which help prepare patients for rapid recovery, resulting in reduced complications, shorter hospital stays, and, primarily, lower hospital costs. On the other hand, the increase in surgical waiting lists has also led to a rise in home mortality due to cardiac causes. Thus, among the various challenges imposed by the current scenario, the investigators believe that preparing patients for rapid recovery after coronary artery bypass grafting presents an opportunity for the sustainability of the healthcare system. Therefore, the aim of this project is to evaluate the impact of a technology platform based on ERAS on the postoperative recovery time of patients undergoing coronary artery bypass grafting in reference centers in the state of São Paulo, Timely Project - REPLICCAR III.
- Conditions
- ERAS, Cardiac Surgery, Cardiac Surgery-CABG, Digital Health
- Being tested
- ERACS with Digital Platform
- Keywords
- Cardiac Surgery, CABG, ERASCS, ERAS, Digital Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERACS with Digital PlatformOther
Also called ERACS, Enhanced Recovery After Cardiac Surgery, Digital ERAS
The assistance provided to patients in the intervention group will be sequential and prospective. The project will utilize an app based on protocols that prepare patients for rapid recovery (ERAS), starting before surgery and extending up to 30 days post-discharge. This includes pre-operative evaluations (psychological, nutritional, and others), scheduling and confirming hospital admission, and following specific protocols during surgery and intensive care. The app aims to enhance communication and teamwork, improving patient-centered care. It will feature modules for patient and family education, team communication, and activity management through a dashboard. Additionally, it will facilitate interaction with patients through messages and surveys, monitor multidisciplinary team communication, and collect patient-reported outcomes 30 days after the surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Standard care for CABG | No intervention | Patients will be treated with CABG following the standard of care for each participant institution. |
| ERACS with Digital Platform | Experimental | Patient will be treated by the participant institution following a modified protocol based in the ERACS with the aid of a digital platform. Receives: Other: ERACS with Digital Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lenght of Stay
Compare the length of stay after coronary artery bypass grafting (CABG) with versus without the use of a technology platform based on ERAS.
Measured: up to 30 days after surgery
Secondary outcomes (4)
Percentage of Completeness of Protocol Steps
Compare adherence to protocol metrics through measure of the execution of the protocol steps by each participant center, during the intervention period. up to one week after surgery.
Measured: up to 01 week after surgery.
Morbility and Mortality
Compare morbidity and mortality rates and hospital readmission between the control and intervention groups up to 6 months after CABG.
Measured: up to 6 months after surgery
Patient-reported outcomes (PROM)
Evaluate and patient-reported outcome measures following the questionnaire published by Ben-Ali W, Lamarche Y, Carrier M, Demers P, Bouchard D, El-Hamamsy I, et al. Use of Mobile-Based Application for Collection of Patient-Reported Outcomes in Cardiac Surgery. Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery. 2021 Nov 1;16(6):536-44. at 01 month and 6 months after surgery.
This questionary assess self reported pain, quality of recovery, anxiety and engagement of the patient with his/her recovery.
Measured: up to 6 months after surgery
Patient reported experience measure(PREM)
Assessment of patient experience using the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.
Measured: up to 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start10 Mar 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ERASStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multicenter, randomized using the stepped-wedge cluster desing
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Dante Pazzanese de Cardiologia, Irmandade da Santa Casa de Misericordia de Sao Paulo, Santa Casa de Misericórdia de Marília, Beneficência Portuguesa de São Paulo
- Responsible party
- Principal investigator, Omar Asdrúbal Vilca Mejia, University of Sao Paulo General Hospital
- Investigators
- Omar A V Mejia, MD, PhD, Principal investigator, InCor - Instituto do Coração do Hospital das Clínicas da FMUSPPedro H Reis, MD, Study chair, InCor - Instituto do Coração do Hospital das Clínicas da FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786819
- Sponsor's protocol ID
- 5811/24/022
- Acronym
- REPLICCARIII
- Status last verified
- Jul 2026
- First submitted
- 7 Nov 2024
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Borgomoni GB, Reis PH, Pinheiro G, Ribas FF, Silva GSD, Campagnucci VP, Issa M, Farsky PS, Barg MM, Tiveron MG, Dos Reis Falcao LF, Dias RD, Ferreira Lisboa LA, Jatene FB, Mejia OAV. The technological proposal based on enhanced recovery after cardiac surgery for changing traditional care in Latin America: REPLICCAR III Study Protocol. PLoS One. 2025 Dec 31;20(12):e0338301. doi: 10.1371/journal.pone.0338301. eCollection 2025.
PubMed 41474739
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudo Randomizado de Cluster Escalonado Para Avaliar o Impacto de Uma Plataforma tecnológica Baseada no ERAS (Enhanced Recovery After Surgery) no Tempo de permanência após Cirurgia de revascularização miocárdica: Projeto Tempos Certos - REPLICCAR III
- ClinicalTrials.gov ID
- NCT06786819
- Acronym / sponsor ID
- REPLICCARIII / 5811/24/022
- Conditions
- ERAS, Cardiac Surgery, Cardiac Surgery-CABG, Digital Health
- Keywords
- Cardiac Surgery, CABG, ERASCS, ERAS, Digital Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Instituto Dante Pazzanese de Cardiologia, Irmandade da Santa Casa de Misericordia de Sao Paulo, Santa Casa de Misericórdia de Marília, Beneficência Portuguesa de São Paulo
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiovascular diseases continue to be the leading cause of death worldwide. Among them, coronary artery disease has the greatest impact, being characterized as one of the main causes of death in Brazil over the last decade. One of the well-established treatments is coronary artery bypass grafting, which is the most performed among cardiac surgeries and, in our scenario, is primarily funded by the Unified Health System (SUS). The information obtained from the Paulista Registry of Cardiovascular Surgeries (REPLICCAR), in partnership with FAPESP, has been important for implementing improvements in the landscape of cardiac surgeries in the state of São Paulo. Although outcomes in cardiac surgery have improved due to the structuring and organization of quality programs, this is still not a reality at the national level. In a situation where data collection and quality initiatives play a central role in continuous improvement, generating value becomes essential for the sustainability of cardiac surgery programs. In this sense, the concept of Enhanced Recovery After Surgery (ERAS) has gained increasing traction. This concept is based on multidisciplinary protocols and scientific evidence, which help prepare patients for rapid recovery, resulting in reduced complications, shorter hospital stays, and, primarily, lower hospital costs. On the other hand, the increase in surgical waiting lists has also led to a rise in home mortality due to cardiac causes. Thus, among the various challenges imposed by the current scenario, the investigators believe that preparing patients for rapid recovery after coronary artery bypass grafting presents an opportunity for the sustainability of the healthcare system. Therefore, the aim of this project is to evaluate the impact of a technology platform based on ERAS on the postoperative recovery time of patients undergoing coronary artery bypass grafting in reference centers in the state of São Paulo, Timely Project - REPLICCAR III.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, multicenter, randomized using the stepped-wedge cluster desing
| Arm | Type | Receives |
|---|---|---|
| Standard care for CABG | No intervention | –Patients will be treated with CABG following the standard of care for each participant institution. |
| ERACS with Digital Platform | Experimental | Other: ERACS with Digital PlatformPatient will be treated by the participant institution following a modified protocol based in the ERACS with the aid of a digital platform. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults over 18 years old
- Indication for primary isolated CABG (elective or urgent status)
- Own a personal cell phone
- Have internet access
- Knowledgeable in using the device
Key exclusion criteria (9 listed)
- Indication for associated surgery
- Glycosylated hemoglobin level greater than 8%
- Creatinine clearance less than 30 mL/min
- Pre-operative atrial fibrillation or use of pre-operative anticoagulation
- Hemoglobin less than 12 g/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERACS with Digital PlatformAlso: ERACS, Enhanced Recovery After Cardiac Surgery, Digital ERASThe assistance provided to patients in the intervention group will be sequential and prospective. The project will utilize an app based on protocols that prepare patients for rapid recovery (ERAS), starting before surgery and extending up to 30 days post-discharge. This includes pre-operative evaluations (psychological, nutritional, and others), scheduling and confirming hospital admission, and following specific protocols during surgery and intensive care. The app aims to enhance communication and teamwork, improving patient-centered care. It will feature modules for patient and family education, team communication, and activity management through a dashboard. Additionally, it will facilitate interaction with patients through messages and surveys, monitor multidisciplinary team communication, and collect patient-reported outcomes 30 days after the surgical procedure. | Other | ERACS with Digital Platform |
Primary outcome
Lenght of Stay
Time frame: up to 30 days after surgery
Compare the length of stay after coronary artery bypass grafting (CABG) with versus without the use of a technology platform based on ERAS.
4 secondary outcomes
Percentage of Completeness of Protocol Steps
Time frame: up to 01 week after surgery.
Morbility and Mortality
Time frame: up to 6 months after surgery
Patient-reported outcomes (PROM)
Time frame: up to 6 months after surgery
Patient reported experience measure(PREM)
Time frame: up to 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Derived from this study: PubMed 41474739Borgomoni GB, Reis PH, Pinheiro G, Ribas FF, Silva GSD, Campagnucci VP, Issa M, Farsky PS, Barg MM, Tiveron MG, Dos Reis Falcao LF, Dias RD, Ferreira Lisboa LA, Jatene FB, Mejia OAV. The technological proposal based on enhanced recovery after cardiac surgery for changing traditional care in Latin America: REPLICCAR III Study Protocol. PLoS One. 2025 Dec 31;20(12):e0338301. doi: 10.1371/journal.pone.0338301. eCollection 2025.
- Instagram REPLICCAR IIILink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for ERAS
Active, not recruitingPhase 1
Comparison of Analgesic Efficacy Between Ultrasound Guided Serratus Anterior Plane Block or Thoracic Paravertebral Block Versus Intravenous Fentanyl for On-pump Coronary Artery Bypass Graft Surgery
Intra and Post Operative Pain Management, Fast Track Program,(Enhanced Recovery After Surgery (ERAS))
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
Not yet recruiting
Planned Operating-Room Extubation After Cardiac Surgery
Mechanical Ventilation, Cardiac Surgery
Not yet recruitingPhase 3
Suzetrigine Post DIEP
Post-operative Pain, DIEP Flap Breast Reconstruction
RecruitingObservational study
Opioid-Free Anesthesia in FESS: A Prospective ERAS Study
Chronic Sinusitis, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Omar A V Mejia, MD, PhD principal investigator
InCor - Instituto do Coração do Hospital das Clínicas da FMUSP
Pedro H Reis, MD study chair
InCor - Instituto do Coração do Hospital das Clínicas da FMUSP
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERACS with Digital Platform in people with ERAS and Cardiac Surgery, run by University of Sao Paulo General Hospital at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omar A V Mejia, MD, PhD (+551126615014, omar.mejia@incor.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lenght of Stay (time frame: up to 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06786819, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.