Towards a Sex-specific "Female Enhanced Recovery After Cardiac Surgery'' (F-ERAS) Pathway: An Observational Registration and Evaluation of Characteristics and Perioperative Management of Cardiac Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,500
- 试验地点
- 1
- 主要终点
- Primary endpoint
研究概览
简要总结
The aim of this study is to evaluate the differences between men and women undergoing cardiac surgery. We will look at perioperative factors such as body weight, body surface area, previous medical history, pharmacokinetics, transfusion, coagulation, cardiopulmonary bypass (CPB) related factors, cardiac function, inotropic requirements, risk, and outcome scores as well as morbidity and mortality at 30 and 90 days, 1, 5, and 10 years.
详细描述
Observational, multicentre, retrospective data collection from the mandatory Quality Assurance database (the Netherlands Heart Registry, (NHR), supplemented with data from the electronic patient files (EPIC). The retrospective data is already available.
In addition, we will continue the retrospective study into a prospective registry of data after the analysis of the retrospective data. Patients will be approached one, five and ten years after the operation and a questionnaire will be sent to document quality of life. No research-related interventions other than questionnaires will be performed
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 > 18 years
- •All patients who underwent cardiac surgery from 1 January 2016 to the start of the study, in either of the centres (AMC or VUmc) (retrospective)
- •All patients undergoing cardiac surgery from the start of the study (~March 2022) until approximately 2032
排除标准
- •Patients who object to the re-use of their care data or do not give consent
结局指标
主要结局
Primary endpoint
时间窗: up to 30 days post-surgery
Number of specific (coagulation), transfusion products,
Primary outcome
时间窗: up to 30 days post-surgery or if still in hospital, until discharge
Times: surgical, cross-clamp, bypass, anesthetic, intensive care admission, hospital admission, etc.
次要结局
- Health related Quality of life measured by PROMS(At 1, 5 and 10 years)
- Morbidity and mortality(At 30, 90, 365 days)
- Survival(At 5 and 10 years)
研究者
Jennifer Breel
Investigator
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)