Personalized (Demand-Informed) Blood Transfusion Protocol for Cardiac Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Number of participants with the composite of all-cause mortality, myocardial infarction, stroke, or new renal failure requiring dialysis
研究概览
简要总结
This study compares two accepted ways of deciding when adults recovering from open-heart surgery should receive a blood transfusion in the intensive care unit. One approach gives a transfusion when the blood count (hemoglobin) falls below a fixed level that is the same for everyone. The other approach adds each patient's own physiology - such as oxygen levels and lactate - to help decide whether a transfusion is truly needed, within a safe range. The investigators want to learn whether the personalized approach is as safe as the standard approach for major outcomes after heart surgery, while reducing the amount of blood transfused. Participants may also choose to give blood and stool samples to a research biobank for future studies on recovery after cardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 years or older scheduled for cardiac surgery using the heart-lung machine (cardiopulmonary bypass), such as bypass, valve, or combined procedures
- •Moderate-to-high surgical risk (e.g., EuroSCORE II ≥ 3% or equivalent)
- •Allogeneic red blood cell transfusion is considered likely
- •Able to provide informed consent and understand randomization to different transfusion thresholds
- •Willing to receive blood products and follow study transfusion thresholds from anesthesia induction until hospital discharge or day 28, whichever comes first
排除标准
- •Refusal of or contraindication to allogeneic blood (e.g., Jehovah's Witness or formal directive against transfusion), or enrollment in a preoperative autologous donation program
- •Emergency or salvage procedures where protocol triggers are impractical (e.g., active arrest, aortic dissection with collapse)
- •Heart transplantation, durable ventricular assist device implantation, or surgery solely for VAD insertion
- •Off-pump bypass or other procedures not using cardiopulmonary bypass
- •Severe preoperative anemia (e.g., hemoglobin < 8 g/dL) or chronic transfusion-dependent anemia
- •Conditions preventing protocol adherence (e.g., anticipated massive hemorrhage, known bleeding disorder, very low platelets, uninterruptible dual antiplatelet/anticoagulant therapy)
- •Chronic dialysis dependence or established end-stage renal disease (eGFR < 15 mL/min/1.73m² or on maintenance renal replacement therapy) prior to surgery.
- •Pregnancy or lactation
- •Enrollment in another interventional trial affecting transfusion practice or hemoglobin thresholds
- •Unable to provide informed consent (e.g., severe cognitive impairment without a legally authorized representative)
研究组 & 干预措施
Standard Restrictive Threshold (Control)
Beginning on arrival to the cardiac ICU after surgery, transfusion of red blood cells is generally recommended when hemoglobin is below 7.5 g/dL, consistent with current institutional practice and major restrictive-threshold trials. Standard surgical, anesthesia, perfusion, monitoring, and postoperative care are provided to all participants.
干预措施: Demand-Informed Transfusion Decision Rule (Other)
Demand-Informed (Personalized) Strategy (Experimental)
Beginning on arrival to the cardiac ICU, an absolute safety floor recommends transfusion when hemoglobin is below 7.0 g/dL regardless of physiology. Between 7.0 and 7.5 g/dL, transfusion decisions are guided by predefined physiologic markers of oxygen balance (e.g., indexed oxygen delivery, venous oxygen saturation, lactate trends): transfusion may be deferred when markers indicate adequate oxygen delivery and is recommended when markers indicate compromised delivery. At or above 7.5 g/dL the rule does not recommend transfusion. The rule is advisory; clinicians may override at any time, and overrides are recorded.
干预措施: Demand-Informed Transfusion Decision Rule (Other)
结局指标
主要结局
Number of participants with the composite of all-cause mortality, myocardial infarction, stroke, or new renal failure requiring dialysis
时间窗: In-hospital for the index procedure or within 28 days of surgery, whichever is longer
Composite event = occurrence of any one of the following, each component also reported separately: All-cause mortality - death from any cause occurring in-hospital during the index-procedure admission or within 28 days of surgery, whichever is longer. Myocardial infarction - per the Fourth Universal Definition of Myocardial Infarction (Type 5, CABG-related, applying the post-cardiac-surgery biomarker thresholds together with supporting ECG, imaging, or angiographic evidence). Stroke - a new focal neurological deficit of central origin lasting ≥24 hours (or \<24 hours with confirmatory neuroimaging), confirmed by CT or MRI. New renal failure requiring dialysis - new acute kidney injury meeting KDIGO Stage 3 criteria with initiation of renal replacement therapy in a patient not previously on chronic dialysis.
次要结局
- Number of participants with new renal failure requiring dialysis(In-hospital or within 28 days of surgery, whichever is longer)
- Number of participants who die from any cause by 6 months after surgery(6 months after surgery)
- Number of participants who die (all-cause surgical mortality)(In-hospital for the index procedure or within 28 days of surgery, whichever is longer)
- Number of participants with postoperative myocardial infarction(In-hospital or within 28 days of surgery, whichever is longer)
- Number of participants with postoperative stroke(In-hospital or within 28 days of surgery, whichever is longer)
- Number of participants with postoperative acute kidney injury(Through 28 days postoperatively)
- Number of participants with a postoperative infection(Through 28 days postoperatively)
- Duration of intensive care unit stay(From ICU admission to ICU discharge, up to 28 days)
- Duration of hospital stay(From surgery to hospital discharge, an average of up to 28 days)
研究者
Yan Mia Min
Protocol Director
Stanford University