Remote Ischemic Preconditioning to Ameliorate Delayed Ischemic Neurological Deficit After Aneurismal Subarachnoid Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 主要终点
- Visual Analog Scale Score as a Measure of Tolerability
研究概览
简要总结
In remote preconditioning, ischemia in one organ protects distant organs from ischemic insults. e.g. brief induced limb ischemia protects the brain from an otherwise more severe stroke.
The objective of this study is to determine if remote ischemic preconditioning can be safely and effectively instituted in patients with subarachnoid hemorrhage, who are at high risk for developing disabling cerebral ischemia. The investigators will also preliminarily assess if there is evidence for neuroprotection. This will be a Phase 1b study.
Additional objectives are:
- to determine if remote ischemic preconditioning can be safely and effectively instituted in patients with subarachnoid hemorrhage, who are at high risk for developing disabling cerebral ischemia.
- analogously to a dose-escalation study the investigators propose to study the safety and tolerability of increasing durations of limb ischemia until a target time of 10 minutes of limb ischemia has been reached.
详细描述
The investigators propose to study patients with subarachnoid hemorrhage, who generally have a high risk of ischemic stroke in the 2 weeks following the initial bleed, and patients with clipped or coiled aneurysm. The investigators will apply a blood pressure cuff around leg and use it to interrupt the circulation for 5-10 minutes. The investigators will repeat this for a total of 3 times every 24 to 48 hours up to 14 days. The cuff will be inflated for 5-10 minutes and then deflated for 5 minutes. There will be 3 cycles of this. The cuff will be inflated to 200mmHg.
The investigators will first start with 5 minutes of cuff inflation to either the arm or leg. The investigators will determine if this is safe in at least 6 patients. The investigators will then increase the duration of cuff inflation to 7.5 minutes for another 6 patients. If no adverse events are noted the investigators will the proceed to study 10 minutes of inflation in another 6 patients. If no side effects are noted the investigators will then determine that this is well tolerated.
The study will be monitored by a Data Safety Monitoring Board who will make decisions about escalating the duration of cuff inflation. If 2 or more patients develop an adverse event that is related to the procedure the investigators will stop and no longer continue at that level of cuff inflation and the previous level of cuff inflation will be determined to be the safe and tolerated level.
The investigators will collect safety data on adverse events such as tolerability, local tissue trauma or deep vein thrombosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •aneurismal subarachnoid hemorrhage
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.
研究组 & 干预措施
remote limb preconditioning
Subjects with subarachnoid hemorrhage will undergo escalating times of limb ischemia to determine tolerability and safety. The leg will be made transiently ischemic with application of a blood pressure cuff for up to 3 cycles of 10 minutes.
干预措施: remote limb preconditioning (Procedure)
结局指标
主要结局
Visual Analog Scale Score as a Measure of Tolerability
时间窗: 90 days
The visual analogue scale is a pain scale from 0-10, with 10 being maximum pain and is frequently used in research studies assessing patient discomfort.
Number of Patients With Deep Vein Thrombosis for Safety Assessment.
时间窗: 90 days
次要结局
未报告次要终点
研究者
Sebastian Koch
Associate Professor
University of Miami