NCT05363696

The REPLICCAR Registry and The Statewide Quality Improvement Initiative

Paulista Cardiovascular Surgery Registry (REPLICCAR)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 9,723 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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;

Conditions

• Cardiac Surgical Procedures

Interventions

Type	Name	Description
PROCEDURE	Coronary artery bypass grafting (CABG)	Coronary artery bypass grafting surgery procedure
PROCEDURE	Heart valve surgery	Heart valve surgery procedure

Timeline

• Start date: 2013-08-01
• Primary completion: 2016-09-01
• Completion: 2019-08-01
• First posted: 2022-05-06
• Last updated: 2022-05-25

Locations

2 sites across 1 country: Brazil