Remote Ischemic Preconditioning to Ameliorate Delayed Ischemic Neurological Deficit After Aneurysmal Subarachnoid Hemorrhage: a Safety and Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Safety Outcome 3 - number of patients who cannot tolerate the intervention due to discomfort
研究概览
简要总结
The purpose of this study is to learn about protecting the brain from dangerous low blood flow.
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 (Participant)
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
- •Patients with aneurysmal subarachnoid hemorrhage whose initial angiogram show an aneurysm and patients with clipped aneurysm will be eligible for enrollment.
- •Patients will be enrolled within 96 hours of bleeding onset, if informed consent is obtained from the participant or health care proxy, as appropriate.
排除标准
- •Hunt Hess Scale > 4
- •Inability to undergo limb preconditioning due to local wound or tissue breakdown, history of peripheral extremity vascular disease or patient discomfort.
- •Inability to obtain informed consent from the patient or a health care proxy.
- •Ankle-brachial index < 0.7
- •Inability to start limb preconditioning within 4 days of bleeding.
- •Inability to precondition a leg that is not-plegic (that is preserved anti- gravity strength) and has not been accessed for catheter angiography
- •Age<18 years
- •Pregnant women
- •Prisoners
结局指标
主要结局
Safety Outcome 3 - number of patients who cannot tolerate the intervention due to discomfort
时间窗: 90 days
The number of patients who cannot tolerate the intervention due to discomfort.
Safety Outcomes 1 - number of patients who develop deep vein thrombosis and thromboembolism
时间窗: 90 days
The number of patients who develop deep vein thrombosis and thromboembolism in the treatment and control group.
Safety Outcome 2 - number of patients who develop neurovascular injury
时间窗: 90 days
The number of patients who develop neurovascular injury in the treatment and control group.
Safety Outcome 4 - number of patients with cardiovascular events
时间窗: 90 days
The number of patients with cardiovascular events \[defined as hypotension, myocardial ischemia\]
次要结局
未报告次要终点
研究者
Sebastian Koch
Associate Professor of Clinical Neurology
University of Miami