Red Cell Storage Duration Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,481
- 试验地点
- 64
- 主要终点
- The Change in the Composite Multiple Organ Dysfunction Score (MODS) From the Pre-operative Baseline. The Worst Post-operative Values of Each Component of MODS Will be Used to Calculate the Change in MODS.
研究概览
简要总结
The RECESS study will compare the effects of transfusing red blood cell units stored <= 10 days vs. red blood cell units stored >= 21 days, in patients who are undergoing complex cardiac surgery and are likely to need a red blood cell transfusion. The primary hypothesis is that there is a clinically important difference between the effects of shorter-storage red cell units and longer-storage red cell units on clinical outcomes and mortality risk.
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
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>= 12 years old
- •>= 40 kg body weight
- •Scheduled complex cardiac surgery with planned use of median sternotomy.
- •Patients ≥ 18 years must have a Transfusion Risk Understanding Scoring Tool (TRUST) probability score ≥ 3
排除标准
- •Refusal of blood products
- •Planned surgery is minimally invasive
- •Known transfusion reaction history
- •Requirement for washed products, volume reduced products, or products with additive solution removed
- •Expected residual cyanosis with O2 saturation < 90
- •Left ventricular assist device (LVAD) or Extracorporeal membrane oxygenation (ECMO) support pre-operatively or planned need post-operatively
- •Cardiogenic shock requiring pre-operative placement of an Intra-aortic balloon pump (IABP) (IABP done for unstable angina or prophylactically for low ejection fraction is not excluded)
- •Planned Deep Hypothermic Circulatory Arrest (DHCA)
- •Renal dysfunction requiring pre-operative renal replacement therapies such as hemodialysis (HD) or continuous venovenous hemofiltration (CVVH)
- •Planned use of alternative to heparin, e.g. bivalirudin
- •Planned use of autologous or directed donations
- •Prior RBC transfusion during hospitalization for the study-qualifying surgery
- •Prior randomization into the RECESS study
结局指标
主要结局
The Change in the Composite Multiple Organ Dysfunction Score (MODS) From the Pre-operative Baseline. The Worst Post-operative Values of Each Component of MODS Will be Used to Calculate the Change in MODS.
时间窗: Through post-operative day 7, hospital discharge, or death, whichever occurs first
The follow-up MODS used to calculate 7-day ΔMODS from pre-op baseline was based on the worst value of each component of MODS observed through post-op day 7, hospital discharge, or death, whichever occurred first, even if a subject's worst values for different components occurred on different dates. Subjects who died during this time period were assigned the worst possible follow-up MODS score, 24 points, and each component of MODS was set at 4, which is the worst score. If a subject did not die during this time period but had at least one day where the Glasgow Coma Score couldn't be scored \[subject sedated; neurologic function not normal by pre-op history (prior stroke, tumor or trauma sequelae, cognitively challenged, behavioral disorder, etc.) or intra-op history, but currently unable to assess because of sedation\], then a post-op MODS score was set to missing and a 7-day ΔMODS was not computed. The total MODS score ranges from 0 (best possible) to 24 points (worst possible).
次要结局
- Composite of Major Cardiac Events (Death, Myocardial Infarction, Low Cardiac Output, Ventricular Tachycardia, Ventricular Fibrillation)(Through post-operative day 7, hospital discharge, or death, whichever occurs first)
- Change in ALT From Pre-operative Value to Worst Post-operative Value (for Pediatric Subjects Only)(Through post-operative day 7, hospital discharge, or death, whichever occurs first)
- Composite of Major In-hospital Post-operative Complications (Death, Stroke, Myocardial Infarction, Renal Failure, Culture-proven Sepsis/Septic Shock)(Through post-operative day 7, hospital discharge, or death, whichever occurs first)
- Change in Serum Creatinine From Pre-operative Value to Worst Post-operative Value(Through post-operative day 7, hospital discharge, or death, whichever occurs first)
- Change in Lactate From Pre-operative Value to Worst Post-operative Value(Through post-operative day 7, hospital discharge, or death, whichever occurs first)
- Days to First Solid Food(Through post-operative day 28, hospital discharge, or death, whichever occurs first)
- All-cause Mortality(28 days post-surgery)
- Change in Multiple Organ Dysfunction Score From Pre-operative Baseline.(Through 28 days post-surgery, hospital discharge, or death, whichever occurs first)
- Composite of Major Pulmonary Events (Any Mechanical Ventilation From 48 Hours Post-operation to Day 7, Hospital Discharge or Death, Whichever Comes First, or Pulmonary Embolism)(Through post-operative day 7, hospital discharge, or death, whichever occurs first)
- Ventilation Duration(Through post-operative day 28, hospital discharge, or death, whichever occurs first)
- Change in Troponin-I From Pre-operative Value to Worst Post-operative Value(Through post-operative day 7, hospital discharge, or death, whichever occurs first)
- Change in Bilirubin From Pre-operative Value to Worst Post-operative Value(Through post-operative day 7, hospital discharge, or death, whichever occurs first)
- Days to First Bowel Movement(Through post-operative day 28, hospital discharge, or death, whichever occurs first)
- Days Alive and Ventilator Free Through Post-op Day 28(Through post-op day 28)
- Any Mechanical Ventilation More Than 48 Hours Post-operation(48 hours post-operation through day 28, hospital discharge, or death, whichever occurs first)