Estratificação de Risco em Cirurgia de revascularização miocárdica no Brasil: CABG - BraSCORE (Brazilian System for Cardiac Operative Risk Evaluation)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 2,400
- 试验地点
- 5
- 主要终点
- In-hospital mortality
研究概览
简要总结
Grouping relevant demographic and clinical information at specific stratified levels, and in correlation with the required resource sets, represents the possibility to adapt, improve, and innovate in cardiac surgery programs. In this path, the pursuit of implementing large databases for continuous improvement cycles becomes the foundation of the entire process. In Brazil, where structural and socioeconomic differences are significant, the standardization and sustainability of a large database become a major challenge. Projects like REPLICCAR (São Paulo Cardiovascular Surgery Registry) and BYPASS Registry, which were created to identify improvement opportunities, were temporary. The absence of a continuous multicenter registry makes it difficult to understand risk-adjusted patient outcomes and to implement cost-effective quality initiatives. For example, in 2022, the Ministry of Health launched the QualiSUS Cardio program, which began to consider hospital reimbursement not only in terms of surgical volume but also in relation to mortality, length of stay, and readmission rates after cardiac surgery. Changes like this already occur in various scenarios where payers, whether public or private, seek reimbursement through value-based models. However, for this to happen, the results need to be adjusted to patient risk. Otherwise, hospitals treating more severe patients would be at a disadvantage. This study aims to develop CABG-BraSCORE, a risk score to stratify patients referred for CABG surgery, adjusting outcomes to patient risk, and seeking continuous improvement for cardiac surgery programs in Brazil.
详细描述
Study Procedure: Data collection will be conducted from patient records, including demographic characteristics, preoperative status, surgical and postoperative data of CABG surgery, and follow-up up to 30 days post-discharge.
Centers with prospective data collection: Participants will be contacted 30 days after surgery and invited to participate in the study. The Free and Informed Consent Form (FICF) will be applied via telephone (Appendix 1). All FICF sessions will be recorded, downloaded, and stored according to the established study protocols.
Centers with retrospective data collection: Thirty days after surgery, it should be recorded whether there was a return visit to the outpatient clinic, readmission to the institution, the reason for readmission, such as surgical complications, stroke, surgical wound infection, myocardial infarction, and mortality at 30 days. All records should be consulted in the patient's medical record. If there is no information recorded about the patient's return visit, loss to follow-up should be considered. A loss of 20% was considered for the sample composition.
After the telephone FICF, a questionnaire (Appendix 2, within the Cardux platform's "Post-discharge Events" section) will be applied to gather information regarding readmissions, death, adverse events, among others, within 30 days after hospital discharge.
Patient data will be entered into the Cardux platform according to study protocol variables.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients submitted to isolated coronary artery bypass grafting at participating centers
排除标准
- •Emergency or salvage CABG procedures.
- •Associated procedures (e.g., valve surgery, aortic surgery).
- •Missing mandatory data in the registry.
结局指标
主要结局
In-hospital mortality
时间窗: up to 3 months during hospital admission for CABG
death occurring at any point during the hospitalization for surgery, even if after 30 days
30-day mortality
时间窗: 30-days of the procedure
death occurring after discharge from the hospital, but within 30-days of the procedure
次要结局
- Prolonged Hospital Stay(postoperative hospital stay longer than 14 days)
- 30-day readmission(30-days after surgery)
研究者
Omar Asdrúbal Vilca Mejia
MD PhD
University of Sao Paulo General Hospital
