CardioPAT Project - Reducing the Need for Allogenic Blood Transfusion After On-pump Cardiac Surgery With Intra- and Postoperative Use of a New Device: a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- The rate of allogenic transfusion with red blood cells (SAG-M)
研究概览
简要总结
The purpose of this study is to determine whether intra- and postoperative use of the cardioPAT® cell saver decreases the need for allogenic red blood cell transfusion in patients, who undergo open heart surgery (with cardiopulmonary bypass) and preoperatively have an increased risk for bleeding.
详细描述
This scientific study will be conducted as a randomized controlled trial with N = 146, and therefore n = 2 x 73.
Randomization will be carried out as a simple 1:1 randomization in to the following groups:
- Control group: undergo heart surgery with blood conserving strategies that are currently standard routine at Rigshospitalet.
- Interventional group: undergo heart surgery with intra- and postoperative use of the cardioPAT cell saver. The cardioPAT collects blood from the operative site and from the chest tubes, thereafter it washes and concentrates the red blood cells. This blood can then be returned to the patient. Furthermore, this group will also receive the same blood conserving strategies as the control group.
Randomization will be stratified for the inclusion criteria to ensure that the two groups have the same amount of women, men with a hemoglobin under 8 mmol/l and men over 75 years with double procedures.
All legally competent adults who receive an on-pump open heart surgery at the Department of Cardiothoracic Surgery at Rigshospitalet will be screened for participation in this trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All the women
- •Men with a hemoglobin < 8mmol/L
- •Men > 75 years of age with combined procedures, that is combined CABG and valve surgery, regardless of preoperative hemoglobin level
- •Sub-acute patients can be included
排除标准
- •Re-operation within the first 24 hours
- •Known clotting disorders (coagulopathy) or hematological diseases
- •Sepsis, f ex due to Endocarditis
- •Patients who are already enrolled in other studies, where data from the studies are at risk of interfering with each other
- •Jehovah's witnesses
- •Acute surgery (< 24 hours)
研究组 & 干预措施
Control group
Interventional group
For patients in the interventional group we use a CardioPAT cell saver intra- and postoperatively.
干预措施: cardioPAT cell saver (Device)
结局指标
主要结局
The rate of allogenic transfusion with red blood cells (SAG-M)
时间窗: The entire stay at the Department of Cardiothoracic Surgery, Rigshospitalet (approximately one week after surgery)
次要结局
未报告次要终点
研究者
Erika Nodin
Research Scholar
Rigshospitalet, Denmark