A Multicenter Prospective, Randomized Controlled Study of Different Transfusion Thresholds in Cardiac Valve Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,600
- 试验地点
- 1
- 主要终点
- A composite of postoperative morbidity and mortality
研究概览
简要总结
This prospective, randomized controlled study is aimed to figure out suitable transfusion threshold in patients undergoing cardiac valve surgery under cardiopulmonary bypass(CPB). Patients are randomly assigned to restrictive and liberal transfusion group and receive blood transfusion during and after surgery. Compare primary and secondary outcomes of two groups.
详细描述
Patients are randomly assigned to restrictive-threshold group and liberal-threshold group before cardiac group. Patients are included in this research when their Hct meets 24% during CPB.
Arterial blood gas analysis will be done in 0.5h, 1.5h, 2.5h, 3.5h...after CPB start and 0.5h before CPB finish.
Arterial blood gas analysis will be done every 4h in intensive care unit(ICU) and everyday in general ward.
Restrictive-threshold group: The transfusion threshold is Hemoglobin(Hb) ≤ 6.0g/dL or Hct ≤ 18% during CPB; postoperative Hb ≤ 7.0g/dL or Hct ≤ 21% in ICU or general ward.
Liberal-threshold group: The transfusion threshold is Hb ≤ 8.0g/dL or Hct ≤ 24% during CPB; postoperative Hb ≤ 10.0g/dL or Hct ≤ 30% in ICU or general ward.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
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
- •All cardiac valve surgical patients undergoing CPB, isolated valve procedures Informed consent obtained
排除标准
- •Pregnant or maternal women Age less than 18 years or more than 80 years Undergo coronary artery bypass or large cardiac vessels procedure Emergencies Have been attended other researches Unable to receive blood for religious reasons Drug addict or malignant tumor patient
结局指标
主要结局
A composite of postoperative morbidity and mortality
时间窗: Postoperative 6 months
The composite components are postoperative mortality, infectious morbidity(wound infection, septicemia, or sepsis), ischemic event(myocardial infarction, stroke, renal infraction, bowel infraction )
次要结局
- Number of participants with delirium(Postoperative 6 months)
- Length of Postoperative Hospital Stay(From date of discharging from ICU until the date of discharging from hospital or date of death from any cause, whichever comes first, assessed up to 2 months.)
- Number of participants with acute kidney injury(Postoperative 6 months)
- Postoperative thoracic fluid volume in the first 24 hours(The first 24 hours after surgery)
- Duration of mechanical ventilation(From date of the end of surgery until the date of discharging from ICU or date of death from any cause, whichever comes first, assessed up to 2 months.)
- Rate of reoperation(Postoperative 6 months)
- Number of Blood Transfusion(From date of beginning of surgery until the date of discharging from hospital or date of death from any cause, whichever comes first, assessed up to 3 months.)
- Number of participants with new-onset renal failure with dialysis(Postoperative 6 months)
- Length of ICU Stays(From date of the end of operation until the date of discharging from ICU or date of death from any cause, whichever comes first, assessed up to 2 months.)
- Number of participants with postoperative atrial fibrillation(Postoperative 6 months)
- Hospitalization expense(From date of being admitted to hospital until the date of discharging from hospital or date of death from any cause, whichever comes first, assessed up to 3 months)