Efficacy and Safety of Frozen Red Blood Cells for Transfusion in Trauma Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 254
- 试验地点
- 5
- 主要终点
- Tissue Oxygenation
研究概览
简要总结
The purpose of this study is to look at red blood cell (RBC) transfusions in trauma patients and evaluate for any differences between the age of the RBCs and how they were stored. The investigators will specifically look for the following differences between study groups:
- the transfused red blood cells' ability to delivery oxygen to the tissues
- differences in biochemical markers in subjects and units transfused, and
- how the subject's internal organs are working and if they develop any infections
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, Care Provider)
入排标准
- 年龄范围
- 15 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Trauma Service with an Injury Severity Score > 4
- •Require a blood (PRBC) transfusion
- •Transfusion is not emergent
- •Able to obtain consent from patient or appropriate 3rd party prior to 1st transfusion
排除标准
- •Inability to adhere to blood age randomization due to limitations of the blood bank inventory
- •Bilateral hand injuries that prevent StO2 measurements
- •Age < 15
- •Pregnancy
- •Massive transfusion (=/> 10 units in 24 hours) in last 3 months
- •Hemodynamically unstable or need for transfusion in < 3 hours
研究组 & 干预措施
Refrigerated RBCs 0-14 days old
Standard, refrigerated RBC units stored up to 14 days
干预措施: RBC units (Biological)
Refrigerated RBCs 15-42 days old
Standard, refrigerated RBC units stored 15-42 days
干预措施: RBC units (Biological)
Frozen RBCs
RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215.
干预措施: RBC units (Biological)
结局指标
主要结局
Tissue Oxygenation
时间窗: Percentage of baseline (3 hours post transfusion compared to baseline)
Assessment of tissue oxygenation by NIRS in subjects up to 3 hours after PRBC transfusion.
次要结局
- 2,3 DPG Levels After Transfusion(12 hours post transfusion)
- Haptoglobin Levels 12 Hours After Transfusion(12 hours after transfusion)
- Clinical Outcomes - Hospital Days(from time of randomization through hospital discharged, assessed up to 6 months)
- Free Hemoglobin Levels After Transfusion(12 hours after transfusion)
- Clinical Outcomes - Infections(from time of randomization through hospital discharged, assessed up to 6 months)
- Clinical Outcomes - ICU Days(from time of randomization through hospital discharged, assessed up to 6 months)
- Clinical Outcomes - Ventilator Days(from time of randomization through hospital discharged, assessed up to 6 months)
- Clinical Outcomes - Acute Respiratory Distress Syndrome(from time of randomization through hospital discharged, assessed up to 6 months)
- Number of Participants With Acute Renal Failure(from time of randomization through hospital discharged, assessed up to 6 months)
研究者
Martin A Schreiber, MD
Professor & Chief of Trauma
Oregon Health and Science University