Deferoxamine: An Emerging Therapy to Prevent Delayed Cerebral Ischemia After Subarachnoid Hemorrhage
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- delayed cerebral ischemia (DCI)
研究概览
简要总结
The investigators will test the central hypothesis that DFO treatment after SAH may improve cerebrovascular regulation, mitigate ischemic neural injury, and serve as an effective neuroprotectant against delayed ischemic injury after 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
- Quadruple (Participant, Care Provider, Investigator, 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
- •diagnosis of spontaneous SAH
- •impaired cerebral autoregulation on day 2-4 post SAH
排除标准
- •traumatic SAH
- •other central neurological disorders such as tumors, known prior stroke, hemorrhage or vascular malformations
- •pregnancy
- •severe renal disease or anuria
研究组 & 干预措施
Desferrioxamine (DFO)
DFO (20mg/kg/hr) in normal saline IV for 4 hours for 5 consecutive days
干预措施: desferrioxamine (DFO) (Drug)
placebo
normal saline IV for 4 hours for 5 consecutive days
干预措施: placebo (Drug)
结局指标
主要结局
delayed cerebral ischemia (DCI)
时间窗: 6 weeks post hemorrhage
DCI will be defined radiographically as any cerebral infarct on the latest CT scan that was seen within 6 weeks after SAH or before discharge or death, that was not present on admission scan or on the CT scan done within 24 to 48 hours after any aneurysmal treatment procedures. All head CT scans will be reviewed for DCI ascertainment by neuroradiologists blinded to the clinical and TCD data using the standardized protocol.
次要结局
- Clinical outcome at discharge(patient's discharge date, which averages 3-4 weeks post hemorrhage)
研究者
Farzaneh Sorond
BWPO Physician
Brigham and Women's Hospital