Optimization of Transfusion Use and Interest of the Correction of Iron Deficiencies in Cardiac Surgery Under Extracorporeal Circulation (ECC)
概览
- 阶段
- 不适用
- 干预措施
- Iron and vitamin Deficiencies Correction Program
- 疾病 / 适应症
- Surgical Blood Loss
- 发起方
- Clinique Pasteur
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- RBC transfusion rate
- 状态
- 已完成
- 最后更新
- 上个月
概览
简要总结
Preoperative anemia is associated with an important increase in transfusions of red blood cells (RBC) compared to a non-anemic patient in cardiac and non cardiac surgery. Furthermore transfusion is also an independent factor of morbi-mortality with notably an increase in the infectious risk, immunological, an increase of the risk of cardiac decompensation, respiratory decompensation Transfusion Related Acute Lung Injury (TRALI) or Transfusion Associated Cardiac Overload (TACO), and an increase in mortality of 16%.
Management of perioperative transfusion is therefore a public health issue. Since 2010, the World Health Organization (WHO) has been promoting a systematic approach to implement blood management programs for the patient to optimize the use of resources and promote quality and safety of care.
Improving the relevance of transfusion in cardiac surgery could be achieved by optimizing the management of patients around 2 axis:
A:non-drug intervention : Review of Practices to Improve the Management of Perioperative RBC Transfusion
B:drug intervention : Systematic correction of pre- and postoperative iron, vitamin deficiencies and anemia
The aim of this program is to improve the relevance of transfusion in cardiac surgery and to limit the morbidity and mortality induced by transfusion. This program is part of a global project of pre, per and postoperative management of the patient undergoing cardiac surgery programmed under extracorporeal circulation (ECC). It requires a multidisciplinary approach between cardiologists, anesthesiologists and intensivists, perfusionists, cardiac surgeons and paramedical teams to optimize the management of the patient.
研究者
Dr Hélène Charbonneau
Principal investigator, MD, PhD
Clinique Pasteur
入排标准
入选标准
- •Patient scheduled for cardiac surgery under ECC
- •Patient affiliated or beneficiary of a social security scheme
- •Patient having given his consent
排除标准
- •Urgent surgery (less than 48h)
- •Contraindication to iron injection : proven allergic reaction
- •Erythropoietin allergy
- •Protected patients: Majors under some form of guardianship or other legal protection; pregnant, breastfeeding or parturient woman.
研究组 & 干预措施
C Group: PBMc
Patient Blood Management: full program PBMi intervention and Drug intervention (systematic correction of pre- and postoperative iron and vitamin deficiencies, and erythropoietin preoperative treatment for anemic patient)
干预措施: Iron and vitamin Deficiencies Correction Program
I Group: PBMi
Non-drug intervention First part of PBM program (PBMi) Training part for medical care staff to improve transfusion practices
干预措施: PBMi: Training program to improve transfusion practices
C Group: PBMc
Patient Blood Management: full program PBMi intervention and Drug intervention (systematic correction of pre- and postoperative iron and vitamin deficiencies, and erythropoietin preoperative treatment for anemic patient)
干预措施: PBMi: Training program to improve transfusion practices
结局指标
主要结局
RBC transfusion rate
时间窗: Between surgery and hospital discharge, an average of 10 days
Proportion of patient who received at least one RBC transfusion during their hospitalization
次要结局
- Adverse events(between baseline (1 month before surgery) and 3 months after surgery)
- Transfusion parameters(between surgery and hospital discharge, an average of 10 days)
- Blood test parameters(between baseline (1 month before surgery) and 3 months after surgery)
- 6 min walk test(at discharge of the healthcare and rehabilitation units)
- New York Heart Association (NYHA)(between baseline (1 month before surgery) and 3 months after surgery)
- Euro Quality of life 5 dimensions (EQ5D)(between baseline (1 month before surgery) and 3 months after surgery)