Effects of the Sangvia Blood Collection System on Postoperative Infections in Orthopedic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 4
- 主要终点
- Body temperature
研究概览
简要总结
The purpose of this study is to compare the infection rate in patients receiving/not receiving their own blood, collected during surgery, during and after orthopedic surgery.
The hypothesis is that transfusion of autologous salvaged blood may reduce postoperative infection.
详细描述
Postoperative infections (both systemic and wound infections) are complications that should be avoided both due to the discomfort and the risk to the patients and for the corresponding increment of hospital costs.
There are some studies indicating that transfusion of autologous salvaged blood may reduce postoperative infections. This may be due to immunostimulating cytokines released in these products. However, as these cytokines also may cause adverse events as febrile transfusion reactions and activation of the complement and the coagulation cascades, the overall impact may be different.
There are two publications from an Austrian group indicating that allogeneic blood transfusion in orthopedic patients cause increased postoperative infection rate irrespectively of the leukocyte content of the red cell concentrates.
The Austrian studies were not randomized. Therefore, it would be useful to perform a randomized, prospective study where the patients receive transfusion of salvaged blood versus allogeneic red cell concentrate as their primary replacement product, respectively.
The purpose of the pilot study is to evaluate if transfusion of autologous salvaged blood reduces the infection rate in orthopedic patients compared with patients receiving allogeneic blood transfusion. The study is limited to one source of autologous blood; blood collected by the Sangvia Blood Collection System, and the study is partially sponsored by the manufacturer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a risk of needing red cell transfusion after surgery estimated to be above 75%, judged by preoperative hemoglobin concentration and known risk of preoperative bleeding
- •Patients over 16 years of age
- •Patients who have consented to participate
排除标准
- •Patients with a known hemolytic anemia (congenital or acquired)
- •Patients for whom informed consent has not been obtained
研究组 & 干预措施
Allogeneic blood
Allogeneic blood transfusion. Patients in this group will receive allogeneic red cell transfusions.
干预措施: Allogeneic blood transfusion (Procedure)
Autologous blood
Autologous blood transfusion. Patients in this arm will receive per- and postoperatively collected autologous blood collected with the Sangvia Blood Collection System. If teh amount of autologous blood is too small for the clinical need, additional allogeneic blood will be transfused.
干预措施: Autologous blood transfusion (Procedure)
结局指标
主要结局
Body temperature
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 8 days.
The body temperature is measured as a part of infection monitoring.
C-reactive protein (CRP)
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 8 days.
CRP i measured as a part of infection monitoring. Because elevated CRP is expected after surgery it is necessary to measure other parameters to in order to monitor infection.
White blood cells (WBC)
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 8 days.
WBC is measured and is a part of the infection monitoring.
次要结局
未报告次要终点
