Impact of the Reimbursement of Fibrinogen on Transfusion, Mortality and Morbidity in Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Red blood cell transfusion
研究概览
简要总结
This retrospective, single-center observational study aims to evaluate the impact of fibrinogen concentrate reimbursement introduced in Belgium in April 1st, 2020, on transfusion practices in complex cardiac surgery. Adult patients undergoing complex cardiac surgery with cardiopulmonary bypass between Jan 1st 2016 and Dec 31st 2024 at Erasme Hospital will be included. Transfusion strategies and clinical outcomes will be compared between the pre-reimbursement and post-reimbursement periods.
详细描述
Complex cardiac surgery with cardiopulmonary bypass is associated with a high risk of perioperative bleeding and transfusion. Since April 1st, 2020, fibrinogen concentrate has been reimbursed in Belgium, facilitating its use as a first-line treatment in fibrinogen deficiency identified by viscoelastic testing.
This retrospective, observational, single-center cohort study will analyze adult patients who underwent complex cardiac surgery with cardiopulmonary bypass at Erasme Hospital between Jan 1st 2016 and Dec 31st, 2024. Two distinct periods will be compared: a pre-reimbursement period (Jan 1st, 2016 to March 31st, 2020) and a post-reimbursement period (April 1st, 2020 to Dec 31st, 2024).
Clinical, biological, and transfusion-related data will be collected retrospectively from electronic medical records and blood bank databases. The primary objective is to evaluate changes in transfusion practices, including the use of red blood cells, plasma, platelets, fibrinogen concentrate, and prothrombin complex concentrates. Secondary objectives include postoperative bleeding, length of stay in intensive care and hospital, reoperation for bleeding, postoperative complications, and in-hospital mortality.
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 aged ≥ 18 years
- •Complex cardiac surgery under cardiopulmonary bypass (CPB), defined as:
- •Coronary artery bypass grafting combined with valve replacement
- •Replacement of two or more valves
- •Cardiac reoperation
- •Surgery for infective endocarditis
- •Ascending aorta surgery
- •Scheduled or emergency procedures
- •Complete clinical and biological data available (transfusions, hospital stay, complications, tests)
- •Surgery performed between Jan 1st, 2016 and Dec 31st, 2024
排除标准
- •Surgery without cardiopulmonary bypass (CPB)
- •Patients aged < 18 years
- •Pregnancy
- •Patients requiring postoperative extracorporeal membrane oxygenation (ECMO)
研究组 & 干预措施
Pre-reimbursement (Jan 1st, 2016 - march 31st, 2020)
Patients undergoing complex cardiac surgery before fibrinogen reimbursement
Post-reimbursement (April 1st, 2020- Dec 31st, 2024)
Patients undergoing complex cardiac surgery after fibrinogen reimbursement
结局指标
主要结局
Red blood cell transfusion
时间窗: 48 hours
Total number of red blood cell units transfused per patient during the perioperative period.
次要结局
- Use of fibrinogen concentrate(48 hours)
- Plasma transfusion(48 hours)
- Platelet transfusion(48 hours)
- Reoperation for bleeding(28 days)
- ICU length of stay(28 days)
- In-hospital mortality(28 days)