NCT02203292已完成2 期
Transfusion Requirements After Head Trauma
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Hemoglobin difference
研究概览
简要总结
TRAHT is a pilot randomized clinical trial designed to evaluate safety and feasibility of two red blood cells transfusion thresholds in moderate or severe traumatic brain injured patients
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 —（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
- •Moderate or severe traumatic brain injury, defined as Glasgow coma scale less than or equal to 12 at hospital admission
- •Hemoglobin lower than 9.0 g/dL within 7 days from hospital admission
排除标准
- •Glasgow coma scale equal to 3 with dilated pupils bilaterally
- •Previous neurological sequelae
- •Pregnant women
- •Jehovah's Witnesses
- •Hemorrhagic shock at randomization
- •Moribund patients
- •Unable to provide consent
研究组 & 干预措施
Liberal
Active Comparator
Liberal transfusion strategy. Patients will have red blood cells transfused only if Hb < 9.0 g/dL
干预措施: Liberal transfusion strategy (Behavioral)
Restrictive
Experimental
Restrictive transfusion strategy. Patients will have red blood cells transfused only if Hb < 7.0 g/dL
干预措施: Restrictive transfusion strategy (Behavioral)
结局指标
主要结局
Hemoglobin difference
时间窗: 14 days
Hemoglobin difference between restrictive and liberal groups
次要结局
- Number of transfused patients(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Number of red blood cell packages transfused(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Hospital mortality(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- 180 days mortality(Participants will be followed for 180 after hospital discharge)
- Blood stream infection(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Extended Glasgow Outcome Scale at hospital discharge(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Pulsatility index(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Intensity of measures to reduce intracranial pressure(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Hospital length of stay(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Mechanical ventilation free days(28 days)
- Acute Respiratory Distress Syndrome(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- ICU mortality(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Re-bleeding(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- ICU length of stay(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Extended Glasgow Outcome Scale after 6 months(180 days)
- Myocardial Infarction(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Cerebral autoregulation(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Septic Shock(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
研究者
André Luiz Nunes Gobatto
M.D.
University of Sao Paulo
研究点 (1)
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