A Prospective Randomized Controlled Trial Comparing the Effects of Fresh vs. Old Blood on Cerebral Oxygen Extraction in Patients With Traumatic Brain Injuries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- To evaluate the effect of transfusing "fresh" (blood stored less than 5 days) versus "stored" (blood stored for greater than 20 days) packed red blood cells (pRBC) on cerebral oxygen extraction ratio for 24 hours post transfusion
研究概览
简要总结
Donated red blood cells vary in how old they are, that is, how long they have been stored since being collected from donors. Blood that has been donated is stored for a maximum of 42 days, after this time it is expired. That means that red blood cells that are given to patients as a blood transfusion can be anywhere from a few days old to 42 days old. The average age of blood that is given as a blood transfusion in this hospital is 21 days old.
As stored blood gets older its ability to carry oxygen may be reduced. Whether or not this is important in patients with a brain injury is not currently known.
The purpose of this study is to try and determine if fresh blood (less than 5 days old) is better than old blood (greater than 20 days old) in improving the supply of oxygen in patients who have suffered an injury to their brain.
详细描述
PURPOSE
To demonstrate that packed red blood cells (pRBC) less than 5 days old are superior to older (>20days) blood in improving markers of cerebral oxygenation in acutely head injured patients.
HYPOTHESIS
Transfusion of pRBC will result in increased cerebral extraction of oxygen. This effect will be greatest in pRBC stored for a greater length of time.
JUSTIFICATION
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, Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary traumatic brain injury
- •Glasgow Coma Scale < 8
- •Invasive neurological monitoring:
- •External Ventricular Drain
- •Jugular bulb catheter
- •Hemoglobin < 100 g/L and decision has been made by Attending Physician to treat with one unit pRBC
排除标准
- •Ongoing need for blood products
- •Received Packed Red Blood Cells within preceding 24 hours
- •Multiple trauma necessitating ongoing resuscitation
- •Pregnant patients
- •Chronic renal failure
- •Severe sepsis or septic shock
- •Adult respiratory distress syndrome or acute lung injury
- •Presumed unstable neurological status during course of study
- •Lack of informed consent
结局指标
主要结局
To evaluate the effect of transfusing "fresh" (blood stored less than 5 days) versus "stored" (blood stored for greater than 20 days) packed red blood cells (pRBC) on cerebral oxygen extraction ratio for 24 hours post transfusion
时间窗: 20 days
次要结局
- To evaluate the effect of transfusion of pRBC on cerebral oxygen extraction in patients with traumatic brain injury for 24 hours post transfusion.(24 hours)