Safety and Efficacy of Remote Ischemic Conditioning in Patients With Spontaneous Intracerebral Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 530
- 试验地点
- 1
- 主要终点
- Proportion of patients with Modified Rankin Scale (mRS) Score 0-2
研究概览
简要总结
The purpose of this study is to determine whether treatment with remote ischemic conditioning is of sufficient promise to improve outcome before conducting a larger clinical trial to examine its effectiveness as a treatment for intracerebral hemorrhage.
详细描述
Intracerebral hemorrhage is a devastating disease with a high rate of severe disability and death, while no specific treatment has been proven to improve functional outcome. As a result, new approaches need to be developed to treat intracerebral hemorrhage. Animal and human trials showed treatment with remote ischemic conditioning was safe for intracerebral hemorrhage. And repetitive remote ischemic conditioning has been shown to improve sensorimotor and neuropathological outcomes following experimental hemorrhagic stroke. Therefore, we hypothesize that repetitive remote ischemic conditioning could improve functional outcome in patients with intracerebral hemorrhage. We design this prospective, multicenter, randomized controlled double-blind trial to determine whether treatment with remote ischemic conditioning is of sufficient promise to improve outcome before conducting a larger clinical trial to examine its effectiveness as a treatment for 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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Functional independence prior to ICH, defined as pre-ICH mRS ≤ 1
- •NIHSS score ≥ 4 and GCS ≥ 6 upon presentation
- •Able to commence RIC treatment within 12 hours of stroke onset
- •Signed and dated informed consent is obtained.
排除标准
- •Definite evidence of secondary ICH, such as structural abnormality, brain tumor, thrombolytic drug, and other causes
- •A very high likelihood that the patient will die within the next 24 hours on the basis of clinical and/or radiological criteria
- •Already booked for surgical treatment
- •Life expectancy of less than 90 days due to comorbid conditions
- •Severe hematologic disease
- •Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban.
- •Concurrent use of glibenclamide or nicorandil
- •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
- •Platelet count <100×10^9/L
- •Coagulopathy defined as INR,APTT,and PT beyond the upper limit of normal range
- •Known pregnancy, or positive pregnancy test, 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+Standard medical treatment
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 mm Hg. RIC will be conducted twice daily for 7 days. Additionally,the patients will be treated with standard medical treatment according to 2014 chinese guideline for the diagnosis and treatment of intracerebral hemorrhage.
干预措施: Remote ischemic conditioning (Procedure)
Sham RIC+Standard medical treatment
Sham remote ischemic conditioning (Sham RIC) is simulated by the measurement of blood pressure twice daily for 7 days.Additionally,the patients will be treated with standard medical treatment according to 2014 chinese guideline for the diagnosis and treatment of intracerebral hemorrhage.
干预措施: Sham remote ischemic conditioning (Procedure)
结局指标
主要结局
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2
时间窗: 3 months
The primary outcome measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-2 at 90 days.
次要结局
- Frequency of adverse events(3 months)
研究者
Yi Yang
Associated Dean of First Hospital of Jilin University
The First Hospital of Jilin University