Remote Ischemic Conditioning for Safety, Feasibility, and Preliminary Efficacy in Patients With Aneurysmal Subarachnoid Hemorrhage After Aneurysm Clipping: An Open-Label, Evaluator-Blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Proportion of mRS (0-2)
研究概览
简要总结
This study was designed to evaluate the safety and efficacy of remote ischemic conditioning (RIC) in patients with aneurysmal subarachnoid hemorrhage (aSAH) following surgical clipping.
Aneurysmal subarachnoid hemorrhage is a life-threatening condition that occurs when a cerebral aneurysm ruptures, causing bleeding into the subarachnoid space. Surgical clipping of the aneurysm is a standard procedure used to stop the bleeding and prevent re-rupture, thereby stabilizing the patient's condition.
Remote ischemic conditioning (RIC) is a non-invasive treatment that involves using a blood pressure cuff to induce brief, temporary cycles of ischemia and reperfusion in a limb. Research suggests that this process may confer systemic protective effects, potentially improving recovery from brain injury or surgery. Although RIC has shown potential to improve outcomes in patients with other neurological conditions, its effect on patients with aSAH who undergo surgical clipping remains unclear.
This study will evaluate whether RIC can reduce complications, improve neurological function, and enhance overall recovery in these patients. The findings will help determine whether RIC should be incorporated into the standard treatment regimen for aSAH.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Imaging examination confirmed aneurysmal subarachnoid hemorrhage.
- •Responsible aneurysms received craniotomy clipping within 24 hours.
- •18≤ age ≤80 years old.
- •Informed consent of the participant or legally authorized representative
排除标准
- •Patients with other types of cerebral hemorrhage.
- •Prior neurological impairment (mRS Score >1) or mental illness may confuse neurological or functional assessment.
- •Severe comorbidities with a life expectancy of less than 90 days.
- •Refractory hypertension (systolic blood pressure 180>mmHg or diastolic blood pressure 110>mmHg).
- •RIC contraindications: severe soft tissue injury of lower limbs.
- •Simultaneously participate in another research program to study a different experimental therapy.
- •Any condition that the investigator believes may increase the patient's risk.
研究组 & 干预措施
control group
Guideline-based therapy
干预措施: Guideline-based therapy (Other)
RIC Group
Guideline-based therapy + RIC (200 mmHg, bid, 7d)
干预措施: Remote Ischemic Conditioning Treatment Instrument (Device)
RIC Group
Guideline-based therapy + RIC (200 mmHg, bid, 7d)
干预措施: Guideline-based therapy (Other)
结局指标
主要结局
Proportion of mRS (0-2)
时间窗: 90±7 days post-enrollment in the study
Modified Rankin Scale, mRS; min:0, max:6; A smaller score indicates a better prognosis.
Proportion of mRS (0-2)
时间窗: 90±7 days post-enrollment in the study
Modified Rankin Scale, mRS; min:0, max:6; A smaller score indicates a better prognosis.
incidence rate of RIC adverse events
时间窗: From enrollment to the end of RIC at 1 week
RIC adverse events mainly include: limb pain, skin damage, deep vein thrombosis, transient hypertension, etc.
次要结局
- mRS Score as ordinal variable(30±7 days post-enrollment in the study)
- incidence rate of aSAH complications(From enrollment to 90 days post-enrollment)
- mRS Score as ordinal variable(30±7 days post-enrollment in the study)
- mRS Score as ordinal variable(7±1 days post-enrollment in the study)