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临床试验/NCT04040023
NCT04040023
已完成
不适用

Optimization of Transfusion Use and Interest of the Correction of Iron Deficiencies in Cardiac Surgery Under Extracorporeal Circulation (ECC)

Clinique Pasteur1 个研究点 分布在 1 个国家目标入组 900 人2019年9月10日

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.

注册库
clinicaltrials.gov
开始日期
2019年9月10日
结束日期
2021年9月23日
最后更新
上个月
研究类型
Interventional
研究设计
Sequential
性别
All

研究者

责任方
Sponsor
主要研究者

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)

研究点 (1)

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