NCT02483351已完成2 期
Aneurysmal Subarachnoid Hemorrhage: Red Blood Cell Transfusion and Outcome - A Pilot Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Randomization Rate
研究概览
简要总结
The purpose of this study is to determine the feasibility of conducting a large trial examining the effect on clinical outcome of a liberal red blood cell (RBC) transfusion strategy compared to a restrictive strategy (usual care) in patients with aneurysmal subarachnoid hemorrhage (SAH).
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)
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 presentation
- •First ever episode aneurysmal SAH
- •Confirmed aneurysmal SAH diagnosis: as confirmed by treating Neurosurgeon or Neuro-interventionalist and supported by blood in subarachnoid space (demonstrated on cranial imaging or cerebrospinal fluid positive for xanthochromia) that is the result of a ruptured saccular aneurysm (confirmed by cranial imaging - cranial topography or magnetic resonance imaging angiography or catheter angiogram)
- •Incident hemoglobin ≤100g/L within 14 days following SAH (defined by first day of hospital presentation)
排除标准
- •Physician and or family decision to withdraw/withhold critical care at time of enrolment
- •Active bleeding with hemodynamic instability at time of enrolment
- •Patients with contra-indication or known objection to blood transfusions
- •SAH due to causes other than saccular aneurysm rupture including mycotic, traumatic and dissecting aneurysms, and aneurysms associated with arteriovenous malformations.
研究组 & 干预措施
Restrictive RBC Transfusion Strategy
Active Comparator
干预措施: Restrictive Red Blood Cell Transfusion Strategy (Other)
Liberal RBC Transfusion Strategy
Experimental
干预措施: Liberal Red Blood Cell Transfusion Strategy (Other)
结局指标
主要结局
Randomization Rate
时间窗: 12 months
次要结局
未报告次要终点
研究者
Shane English
Associate Scientist
Ottawa Hospital Research Institute
研究点 (4)
Loading locations...
相似试验
已完成
不适用
SAHaRA: A Randomized Controlled TrialSubarachnoid Hemorrhage, AneurysmalNCT03309579Ottawa Hospital Research Institute742
进行中（未招募）
1 期
Ferritin and Iron Burden in SAH sIRBDementiaSAHNCT03754725Duke University66
已完成
1 期
Effect of Red Blood Cell Transfusion on Brain Metabolism in Patients With Subarachnoid HemorrhageVasospasmSubarachnoid HemorrhageNCT00968227Washington University School of Medicine56
终止
1 期
Treatment of Subarachnoid Hemorrhage With Human AlbuminSubarachnoid HemorrhageNCT01747408Baylor College of Medicine47
Unknown
不适用
Neuroinflammation and Bispectral Index After Subarachnoid HemorrhageSubarachnoid HemorrhageNCT01516671Ludwig-Maximilians - University of Munich40