A Randomized Clinical Trial of Restrictive vs. Traditional Blood Transfusion Practices in Burn Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 347
- 试验地点
- 36
- 主要终点
- Incidence of Blood Stream Infection
研究概览
简要总结
The purpose of this study is to find out if burn injured patients do better receiving fewer blood transfusions than what is traditionally given. We traditionally provide blood transfusions to maintain a hemoglobin level, which is an indicator of the level of red blood cells that carry oxygen in your body, to above 10 g/dl (g/dl stands for grams per deciliter and is the standard measurement used to indicate the level of red blood cells in your blood). However, a preliminary study indicated that maintaining the hemoglobin level to above 7-8 g/dl with less blood transfusion, as compared to a hemoglobin level of 10 g/dl and above, would reduce the occurrence of blood infection, duration on the respirator and length of hospital stay, yet would achieve similar survival in both groups.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>20% TBSA burn with anticipated operation need on admission as determined by attending physician
- •age >18 years
- •Admission within 96 hours of injury
排除标准
- •<18 years of age
- •pregnancy
- •inability or unwillingness to receive blood products
- •history of chronic anemia (hemoglobin <9.0 g/dL one month prior to enrollment)
- •preexisting need for hemodialysis
- •brain death or imminent brain death
- •non-survivable burn as determined by the attending burn surgeon
- •angina or acute myocardial infarction
- •preexisting hematologic disease
- •Length of hospital stay anticipated to be < 2 weeks
- •Transfusion administered at outside hospital before admit
结局指标
主要结局
Incidence of Blood Stream Infection
时间窗: 1 week after randomization and weekly thereafter through discarge from hospital
次要结局
未报告次要终点