Point-of-Care RBC Washing to Prevent Transfusion-Related Pulmonary Complications
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 171
- 试验地点
- 4
- 主要终点
- Biomarkers Associated With Transfusion-Related Acute Lung Injury and Transfusion Associated Circulatory Overload.
研究概览
简要总结
This study is designed to determine if point-of-care washing of allogeneic Leukocyte-Reduced Red Blood Cells reduces pulmonary complications when compared to standard-of-care Leukocyte-Reduced Red Blood Cells in a cardiac surgical population.
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
- Single (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
- •Age equal to or greater than 18 years of age.
- •Scheduled to have cardiac bypass surgery at Mayo Clinic in Rochester, Minnesota or Duke University Medical Center in Durham, North Carolina
- •At risk for needing at least 4 units of blood during/after surgery
排除标准
- •Emergency surgery
- •Immunoglobulin A (IgA) deficiency
- •History of severe recurrent transfusion reactions
- •Refusal to receive allogeneic blood products
- •Refusal to provide informed consent
- •Prevalent lung injury prior to randomization
- •Prevalent congestive heart failure prior to randomization
- •Expected hospital stay < 48 hours
- •Not anticipated to survive > 48 hours
- •Previously enrolled in this trial
- •No plan for placement of a pulmonary artery catheter
- •Use of home oxygen therapy
- •Complex RBC antibody profiles
- •Need for the use of irradiated RBCs
结局指标
主要结局
Biomarkers Associated With Transfusion-Related Acute Lung Injury and Transfusion Associated Circulatory Overload.
时间窗: 18 hours after the initiation of the first red blood cell transfusion.
This panel of biomarkers measures inflammation, altered coagulation, and endothelial activation all of which play key roles in the pathogenesis of lung injury.
Number of "Off-protocol" Transfusions
时间窗: Day of surgery. Approximately 1 day.
The number of standard issued red blood cell units that were transfused to study participants in the washed red blood cell arm of the trial. Additionally, emergency red blood cell transfusions in the standard issued arm of the trial that were administered outside of the study protocol were also included to the definition of "off protocol" transfusion.
Change in Recipient Hemoglobin
时间窗: Pre to 6 hours post transfusion
Change in Hemoglobin from pre-transfusion to post-transfusion
Change in Recipient Cell Free Hemoglobin(CFH)
时间窗: Pre transfusion until study day 5 or hospital discharge, approximately 5 days
Change in CFH from pre-transfusion to worst (highest/maximum) post-transfusion
Change in Haptoglobin
时间窗: Pre transfusion to study day 5 or hospital discharge, approximately 5 days
Change in Haptoglobin from pre-transfusion to worst (minimum) post-transfusion
次要结局
- Duration of Mechanical Ventilation(Up to hospital day 28, or discharge, whichever comes first)
- Duration of Oxygen Supplementation(Up to day 28, or hospital discharge, whichever comes first)
- Sequential Organ Failure Assessment (SOFA) Score(Through postoperative day 5.)
- Hospital Length of Stay(Up to day 28)
- Post Transfusion Respiratory Complications.(Up to day 28)
研究者
Daryl J. Kor, M.D.
Associate Professor of Anesthsiology
Mayo Clinic