Remote Ischemic Conditioning for Efficacy in Patients With Aneurysmal Subarachnoid Hemorrhage: a Multi-center, Randomized, Double-blind, Sham-controlled, Parallel-group Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Proportion of mRS (0-2)
研究概览
简要总结
Several recent large-scale clinical trials aimed at improving subarachnoid hemorrhage(SAH) outcomes have concluded with negative results, failing to enhance the prognosis for these patients. Consequently, there is an urgent demand for novel treatment strategies and approaches to address the challenges posed by SAH.
Remote ischemic conditioning(RIC) has gained considerable attention in the treatment of stroke, particularly ischemic stroke, with numerous studies demonstrating its potential to enhance neurological outcomes compared to conventional treatments alone.RIC for the treatment of SAH is an investigative strategy in its initial stages. The neuroprotective effects of RIC, particularly its potential to preserve cranial nerve function and ameliorate neurological deficits, confer significant value in the treatment of SAH patients.
The precise manner in which SAH patients may benefit from RIC treatment, and the mechanisms by which it improves neurological function, remain to be fully understood. Consequently, randomized controlled trials are necessary to validate the efficacy of RIC in this patient population and to delineate the optimal therapeutic protocols for its application.
Based on the above discussion, this study aims to explore the efficacy and safety of RIC in the treatment of 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with aneurysmal subarachnoid hemorrhage confirmed by imaging examination (diagnosed by computed tomography and confirmation of an intracranial aneurysm by CT angiography or digital subtraction angiography);
- •The Hunt-Hess grade is 2-3 at admission;
- •Onset of aneurysmal subarachnoid hemorrhage ≤72 hours;
- •The responsible aneurysm has been treated by endovascular interventional therapy;
- •18≤ age ≤80 years old;
- •Informed consent must be obtained from participants or legally authorized representatives.
排除标准
- •Patients with other intracerebral hemorrhage or other types of subarachnoid hemorrhage;
- •Previous neurological deficits (mRS Score ≥1) or psychiatric disorders that can confound neurological or functional assessments;
- •With severe comorbidities and a life expectancy of less than 90 days;
- •Refractory hypertension (Systolic blood pressure> 180 mmHg or diastolic blood pressure >110 mmHg);
- •Contraindications of RIC: severe soft tissue injury of the lower limbs, etc;
- •Concurrent participation in another protocol investigating a different experimental therapy;
- •Any condition that the investigator believes may increase the patient's risk.
结局指标
主要结局
Proportion of mRS (0-2)
时间窗: 90±7 days
Modified Rankin Scale, mRS; min:0, max:6; A smaller score indicates a better prognosis.
次要结局
- Proportion of mRS (0-1)(90±7 days)
- mRS Score as ordinal variable(30±7 days)
- Cognitive function score as ordinal variable(7±1 days)
- The complete blood count(During hospitalization)