HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 742
- 试验地点
- 35
- 主要终点
- extended Glasgow Outcome Scale (GOSe)
研究概览
简要总结
Most trauma deaths are related to traumatic brain injury (TBI). Although the management of patients has improved, mortality remains unacceptably high, and half of survivors of moderate and severe TBI are left with major functional impairment. Current management guidelines are based on limited evidence and practice is highly variable. Most acutely ill patients with TBI will develop anemia, which may decrease oxygen delivery to a fragile brain. While clinical practice is moving towards transfusing at low hemoglobin (Hb) levels, experts have expressed concerns regarding restrictive strategies, which may adversely affect clinical outcomes in TBI. Our primary objective is to evaluate the effect of red blood cell (RBC) transfusion thresholds on neurological functional outcome. We hypothesize that a liberal transfusion strategy improves outcomes compared to a restrictive strategy.
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
- Single (Outcomes Assessor)
盲法说明
Open-label with blinded outcome evaluation.
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
- •Acute moderate to severe blunt TBI
- •Glasgow Coma Score [GCS] ≤ 12
- •Hb level ≤ 100 g/L
排除标准
- •Patient has received transfusion after ICU admission
- •Contraindications or known objection to transfusions
- •Glasgow Coma Scale (GCS) of 3 with dilated fixed pupils.
- •Patient is brain dead
- •Active life-threatening bleeding with hemorrhagic shock or requiring urgent surgical procedure
- •A decision to withold or withdraw life-sustaining therapies was made
- •No fixed address
结局指标
主要结局
extended Glasgow Outcome Scale (GOSe)
时间窗: 6 months
Assessment of neurological outcome by the extended Glasgow Outcome Scale (GOSe)
次要结局
- Quality of life (EQ-5D)(6 months)
- Quality of life (Qolibri questionnaires)(6 months)
- Mortality(ICU, Hospital and at 6 months)
- Functional Independence Measure (FIM)(6 months)
- Depression (PHQ-9)(6 months)
研究者
Dr Alexis Turgeon
Professor
CHU de Quebec-Universite Laval