Aneurysmal Subarachnoid Hemorrhage - Red Blood Cell Transfusion and Outcome (SAHaRA): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 742
- 试验地点
- 31
- 主要终点
- Modified Rankin Scale (mRS)
研究概览
简要总结
The SAHaRA trial will clarify the role of treating anemia with Red Blood Cell (RBC) transfusion in a unique and vulnerable patient population, and determine whether that impacts on functional outcomes and mortality. It will guide best practice standards and clarify the optimal RBC transfusion strategy in patients with aSAH.
详细描述
We hypothesize that in adult patients suffering from aSAH and anemia, a liberal RBC transfusion strategy as compared to a restrictive RBC transfusion strategy decreases the combined rate of death and severe disability at 12 months (using the modified Rankin Scale)
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 blinded-endpoint
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 ≥18 years old at time of SAH
- •First ever episode of aneurysmal SAH
- •Diagnosis of aSAH as confirmed by treating physician (eg: neurosurgeon or neuro- interventionalist) and supported by blood in subarachnoid space (e.g. cranial imaging or cerebrospinal fluid positive for xanthochromia, surgical visualization) that is the result of a ruptured aneurysm (e.g. direct visualization, cranial imaging or catheter angiogram)
- •Hb ≤100g/L within 10 days following aSAH (defined by first day of hospital presentation)
排除标准
- •Physician and or family decision to withdraw/withhold active medical care at time of enrolment
- •Active bleeding with hemodynamic instability at time of enrolment
- •Patients with contraindication or known objection to blood transfusions
- •SAH due to mycotic aneurysm, infundibulum and vascular malformations.
结局指标
主要结局
Modified Rankin Scale (mRS)
时间窗: 12 months post
The Modified Rankin Scale (mRS) is a functional outcome measure in stroke. The interview consists of five sections: Constant Care, Assistance to Attend to Bodily Needs/For Walking, Assistance to Look After Own Affairs, Usual Duties and Activities and Symptoms as a Result of Stroke. The scale is scored from 0 reporting no symptoms at all, to 5 reporting severe disability. Death is indicated by a score of 6.
次要结局
- Mortality(12 months post)
- Mechanical Ventilation(up to 21 days)
- Length of Stay(12 months post)
- Transfusion-related Complications(up to 28 days)
- Delayed Cerebral Ischemia and Vasospasm(up to 28 days)
- Functional Independence Measure (FIM)(12 months post)
- Red Blood Cell Transfusions(up to 21 days)
- Cerebral Infarction(up to 28 days)
- EuroQOL Quality of Life Scale (EQ5D)(12 months post)
- Daily Hemoglobin(up to 21 days)