Individualized Strategies of Red Blood Cell Transfusion for Perioperative Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- the volume of red blood cell (RBC) used adjusted to body weight
研究概览
简要总结
The individualized strategies of red blood cell for perioperative pediatric patients are made based on the comparison between the clinical condition score and the Hb concentration.
详细描述
The hypothesis is that the individual transfusion strategies will help to save blood resource, and meanwhile will not adversely affect the patients' clinical outcomes. Participants will be randomly divided into two groups, where the strategies of transfusion of red blood cell will be made following different principles. The strategies for patients in control group will be made by the attending doctors in charge according to the current Chinese red blood cell transfusion guidelines. For the patients in study group, the clinical condition will be identified every time red blood cell transfusion is considered. The strategies will be made according to the comparison between the score and the Hb concentration. The volume of the red blood cell used in these two groups will be compared. The number of patients who need transfusion in these two groups will be compared. The clinical outcomes will also be compared between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The Hb concentration is tested before operation. It is higher than 7g/dl and lower than 10g/dl. Or it is anticipated that it will decrease lower than 10g/dl.
排除标准
- •The patient will not undergo an operation.
- •newborn or premature baby
- •patients accompanied with hemorrhagic disease or cyanotic heart disease
- •patients with ischemic heart disease or ischemic cerebrovascular disease
研究组 & 干预措施
control group
The strategies of red blood cell transfusion for the pediatric patients in this group will be made by the attending doctors in charge based on the current transfusion guidelines. The attending doctors decide when to start blood red cell transfusion and order the volume of the blood red cell as the usual clinical practice.
study group
For study group, the clinical condition score must be identified every time red blood cell transfusion is considered. The strategies of red blood cell transfusion for the pediatric patients in this group, including the trigger and the volume, will be made based on the comparison between the clinical condition score and the Hb concentration.
干预措施: clinical condition score (Diagnostic Test)
结局指标
主要结局
the volume of red blood cell (RBC) used adjusted to body weight
时间窗: baseline through 3 days after surgery
This is a repeated measurement data. The volume of RBC used adjusted to body weight = the volume of RBC (ml) used/ body weight(Kg). It is repeatedly recorded during this time frame. The data for intraoperation phase, for postoperation phase and for both intraoperation and postoperation phase are analyzed.The data would be measured at baseline (before operation), at the end of operation and on the 3rd days after operation.
次要结局
- infection(from the end of operation to the 3rd month after the operation.)
- length of stay in hospital after operation(from the date of operation to discharge （about 1-4 weeks ）)
- the number of patients who need RBC transfusion(baseline through 3 days after surgery)
- blood pressure（Diastolic）(during operation (about 2-6 hours))
- length of stay in post anesthesia care unit (PACU)(about 2-6 hours)
- hemoglobin （Hb） concentration(baseline through 3 days after surgery)
- blood pressure（Systolic）(during operation (about 2-6 hours))
- lactate (Lac)(during operation (about 2-6 hours))
- unexpected transfer to intense care unit (ICU)(from the end of operation to the 3rd day after the operation.)
- heart rate(during operation(about 2-6 hours))