Impact de la Transfusion de Culots Globulaires de Moins de 14 Jours Sur la Morbi-mortalité Chez Des Patients en Chirurgie Cardiaque
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 459
- 试验地点
- 1
- 主要终点
- death / acute renal failure / operating / stroke / postoperative ischemia post infection
研究概览
简要总结
The purpose of the transfusion of packed red blood cell is to overcome acute or chronic anemia cause tissue hypoxia. It increases hemoglobin concentration and consequently increase oxygen delivery to peripheral tissues. The perioperative period of major surgery is a field particularly favorable to the development of tissue hypoxia, which is associated with increased mortality and postoperative morbidity. Optimization of oxygen transport to tissues at the preoperative period is accompanied by a significant reduction of these major complications.
Clinical complications (infectious or otherwise) related to transfusion of caps Red Blood cells Caps (RBC)are well known. Many studies seem to evidence the potentially deleterious effect of transfusion, especially in patients with poor condition, related to storage time. Indeed, during storage, impaired blood-related storage is created. It is metabolic, biochemical and molecular levels. Many studies, carried out in particular in cardiac surgery where patients are suitable for transfusion RBC, have focused on the effect of transfusions on consumption and the transport of oxygen to demonstrate the impact of conservation lesions on their role in vivo. In particular, a single-center retrospective American study showed reduction of postoperative complications in patients who received RBC under 14 days.
However one of the confounding factors present is that all transfused RBCs are not leukoreduced (unlike the French transfusion policy). In addition, the greater part of the clinical studies are controversial. That is why we aim to assess, through a retrospective study of data, the impact of transfusion of red red blood cells within 14 days of post-operative morbidity and mortality, compared to the usual transfusion practice in cardiac surgery patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients male or female over the age of 18 years
- •Patients able to understand the benefits and risks of testing
- •For the study population: patients who underwent cardiac surgery (all surgery combined) scheduled or emergency December 2008 to May 2009, having been transfused intraoperatively and until the seventh postoperative day .
- •For the reference population: patients who have undergone elective or emergency cardiac surgery from December 2007 to May 2008 and from December 2009 to May 2010, having been transfused intraoperatively and until the seventh postoperative day.
排除标准
- •Inability to understand the advantages and disadvantages of the study, psychiatric disorders judged by the investigator to be incompatible with the inclusion in the study.
- •Patients who have expressed opposition to his participation in the study.
- •For the study population: patients were transfused within seven days before the start of the observation period.
- •For the study population: patients with transfusion of red blood cell more than 14 days
- •For the reference population: patients were transfused within seven days before surgery.
结局指标
主要结局
death / acute renal failure / operating / stroke / postoperative ischemia post infection
时间窗: in-beyond the 48th hour of the transfusion
The primary endpoint was the occurrence of death and / or acute renal failure and / or operating and / or stroke and / or postoperative ischemia post infection, in-beyond the 48th hour of the transfusion.
次要结局
- Mortality / average length of stay in intensive care / resuscitation (> 48 hours) / the average length of stay in cardiac surgery(30 days)