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The REPLICCAR Registry and The Statewide Quality Improvement Initiative

Paulista Cardiovascular Surgery Registry (REPLICCAR)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05363696
Acronym
REPLICCAR
Enrollment
9723
Registered
2022-05-06
Start date
2013-08-01
Completion date
2019-08-01
Last updated
2022-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgical Procedures

Keywords

Database, Quality improvement, Mortality, Coronary artery bypass grafting, Heart valve surgery

Brief summary

Cardiovascular diseases remain the leading cause of death for the healthcare system and cardiac surgery has an important impact on their resolubility. Healthcare systems in the world have evolved to optimize their clinical records and thus learn from the real world through the interactivity between results, processes, and structure. When the rate of growth of healthcare costs scenario is greater than the one of Gross Domestic Product of countries, there is a considerable challenge to increment the quality of healthcare services and the primordial patient safety, as well as the necessary control and traceability of implantable devices. The association and correlation of patients' demographic and clinically relevant information with the resources required for the care provided for each stratum represent the possibility to adapt, improve and innovate the healthcare programs; This will allow improving the optimization of the therapeutic protocols and the creation of related research areas, aiming to promote more equitable resources allocation, increase access and effectiveness, as well as to ascertain the magnitude of available and used resources and its impact.

Detailed description

METHODS Extension Cohort study, mandatory, prospective multicenter, in the state of São Paulo and of registry of consecutive cases. Besides the situational diagnostic of the results and comparison between the mean of both registries, there will be the creation of improvement reports for each of the REPLICCAR centers. Next, quality improvement initiatives will be implemented in each center indicated by the reports. Sample * Will be included in a consecutive way all patients that had CABG and heart valve surgery in the participant centers for the defined period; * Data will be collected, independently of surgical volume, severity status, and social condition among others, in sight of the São Paulo state health department; * This way, it will be possible to produce a predictive curve to be used in most clinical case scenarios observed in the state of São Paulo;

Interventions

Coronary artery bypass grafting surgery procedure

Heart valve surgery procedure

Sponsors

Instituto do Coração do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
CollaboratorUNKNOWN
Hospital Samaritano Paulista
CollaboratorOTHER
Hospital Israelita Albert Einstein
CollaboratorOTHER
Beneficência Portuguesa de São Paulo
CollaboratorOTHER
Instituto Dante Pazzanese de Cardiologia
CollaboratorOTHER
Hospital das Clinicas da Universidade Estadual de Campinas
CollaboratorUNKNOWN
Hospital de Base de São Jose do Rio Preto
CollaboratorUNKNOWN
Irmandade da Santa Casa de Misericórdia de Marília
CollaboratorUNKNOWN
Irmandade da Santa Casa de Misericórdia de São Paulo
CollaboratorUNKNOWN
Irmandade da Santa Casa de Misericórdia de Piracicaba
CollaboratorUNKNOWN
Hospital São Paulo da Universidade Federal de São Paulo
CollaboratorUNKNOWN
Hospital Pitangueiras do Grupo SOBAM
CollaboratorUNKNOWN
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
CollaboratorUNKNOWN
University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Age 18- 90 years old. * CABG or heart valve surgery * Agreement to participate in the study signing informed consent documentation.

Exclusion criteria

* Re-operation * Impossibility to access data variables relevant to the study.

Design outcomes

Primary

MeasureTime frameDescription
Create and implementing data driven quality initiatives for cardiac surgery procedures in São Paulo state5 yearsGuided by the database, quality initiatives will be built in order to reduce mortality, length of stay and complications in the centers participating in REPLICCAR.

Secondary

MeasureTime frameDescription
Create a morbidity and mortality risk score5 yearsCreate a morbidity and mortality risk score, in order to guide the care and interventions of patients undergoing cardiac procedures, in order to prevent morbidity and mortality outcomes.
Long-term follow-up of patients included in the database10 yearsLong-term follow-up of patients included in the database, providing an opportunity to assess quality of life, evolution and deaths after hospital discharge.
Assessment of the impact of patients' socioeconomic variation in its surgical evolution10 yearsAssessment of the impact of patients' socioeconomic variation on their evolution in terms of morbidity and mortality (short and long term).

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026