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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 人开始时间: 2019年9月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
900
试验地点
1
主要终点
RBC transfusion rate

研究概览

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

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

Experimental

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 (Drug)

I Group: PBMi

Other

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 (Other)

C Group: PBMc

Experimental

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 (Other)

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)

研究者

申办方类型
Other
责任方
Sponsor
主要研究者

Dr Hélène Charbonneau

Principal investigator, MD, PhD

Clinique Pasteur

研究点 (1)

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