Safety and Efficacy of Remote Ischemic Conditioning for Spontaneous Intracerebral Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 180 days
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning in treating acute intracerebral hemorrhage.
详细描述
Spontaneous intracerebral hemorrhage is a major cause of disability and mortality among different types of stroke, and few effective treatment options are available. Therefore, it is essential to develop new approaches to improve the prognosis of these patients. Recently, remote ischemic conditioning (RIC), a method that involves inducing multiple brief episodes of ischemia and reperfusion in the limbs, has been indicated to exert neuroprotective effects in experimental stroke. The underlying neuroprotective mechanism triggered by RIC induces gene expression, alters pathways, promotes neurogenesis and blood vessel development, reduces oxidative stress and neuronal apoptosis, and inhibits proinflammatory signals. Previously, several clinical trials have shown that single or repeated RIC treatments for cerebrovascular diseases are feasible and safe. Therefore, we hypothesize that RIC could improve functional outcome in patients with intracerebral hemorrhage. We design this prospective, multicenter, randomized controlled trial to evaluate the efficacy and safety of RIC in treating intracerebral hemorrhage.
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
- Double (Participant, 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
- •Age ≥18 years.
- •Supratentorial intracerebral hemorrhage confirmed by brain CT scan.
- •No disability in the community before ICH (premorbid mRS≤ 1).
- •NIHSS score ≥ 6 and GCS ≥ 8 upon presentation.
- •Able to commence RIC treatment within 24 hours of stroke onset.
- •Systolic blood pressure ≤ 180 mmHg before randomization.
- •Signed and dated informed consent is obtained.
排除标准
- •Definite evidence of secondary ICH, such as structural abnormality, brain aneurysm, brain tumor, thrombolytic drug.
- •Hematoma with a mid-line shift, cerebral herniation or isolate intraventricular hemorrhage.
- •Already booked for surgical treatment.
- •Life expectancy of less than 180 days due to comorbid conditions.
- •Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban or coagulopathy (defined as INR, APTT, and PT beyond the upper limit of normal range).
- •Any soft tissue, orthopedic, or vascular injury, wounds or fractures in healthy upper limb which may pose a contraindication for application of RIC.
- •Severe hepatic and renal dysfunction, or ALT/AST >3 times upper limit of normal, or serum creatinine >265umol/l.
- •Known pregnancy or breastfeeding.
- •Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.
- •A high likelihood that the patient will not adhere to the study treatment and follow up regimen.
- •Patients unsuitable for enrollment in the clinical trial according to investigators decision making.
研究组 & 干预措施
RIC group
Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mmHg.
干预措施: Remote ischemic conditioning (Device)
Sham RIC group
Sham remote ischemic conditioning (Sham RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg.
干预措施: Sham remote ischemic conditioning (Device)
结局指标
主要结局
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 180 days
时间窗: 180 days
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2. Ranged from 0 to 6, a low value represents a better outcome.
次要结局
- Ordinal shift of the full range of mRS scores at 90 and 180 days(90 days, 180 days)
- National Institute of Health stroke scale (NIHSS) at 7 days(7 days)
- Hematoma growth at 24 hours(24 hours)
- Adverse events occurring in the course of the study.(6 months)
- Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days(90 days)
研究者
Yi Yang
Associated Dean of First Hospital of Jilin University
The First Hospital of Jilin University