The Safety and Efficacy of Remote Ischemic Conditioning for the Treatment of Intracerebral Hemorrhage: A Multicenter, Randomized, Controlled Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 452
- 试验地点
- 13
- 主要终点
- Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 90 Days
研究概览
简要总结
Intracerebral hemorrhage (ICH) results from the rupture of small vessels damaged by chronic hypertension, amyloid angiopathy or other disease. Currently, ICH has been a devastating type of stroke that lacking effective therapy. Remote ischemic conditioning (RIC), a systematically protective strategy, has been found to have neuroprotective effects by in patients with ischemic stroke. In addition, animal studies show that RIC is safe in ICH model and it could accelerate the absorption of hematoma. In a previous clinical study (RICH-1), RIC have been found to be safe and well-tolerated in patients with ICH. Therefore, the investigators plan to undertake this study to further evaluate the safety and efficacy of RIC in patients with ICH.
The investigators hypothesize that treatment with RIC will accelerate the absorption of hematoma and improve patients' functional outcomes. Results of this study can potentially bring into account new means to improve the outcomes of ICH patients.
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
- •Age ≥ 18 and ≤ 80 years
- •The diagnosis of supratentorial ICH is confirmed by brain CT scan
- •Hematoma volume of 10 to 30 ml and Glasgow Coma Score (GCS)>8 at randomization.
- •National Institutes of Health Stroke Scale (NIHSS)≥6 and ≤20 points at randomization.
- •Randomization and starting treatment between 24 and 48 hours of symptom ictus.
- •Signed and dated informed consent is obtained.
排除标准
- •Planned surgical evacuation of ICH prior to administration of investigational intervention
- •ICH concomitant with subarachnoid hemorrhage or intraventricular hemorrhage
- •Suspected secondary ICH related to tumor, ruptured aneurysm or arteriovenous malformation, hemorrhagic transformation of an ischemic infarct, or venous sinus thrombosis
- •Patients with a pre-existing neurological deficit (mRS>1) or psychiatric disease that would confound the neurological or functional evaluations.
- •Coagulopathy - defined as elevated aPTT or INR >1.3 upon presentation; concurrent use of direct thrombin inhibitors (such as dabigatran), direct factor Xa inhibitors (such as rivaroxaban or apixaban), or low-molecular-weight heparin
- •Severe renal disease (i.e., renal disorder requiring dialysis ) or eGFR <30ml/min/1.73m2
- •Severe liver disorder, or ALT >3 times or bilirubin >2 times upper limit of normal
- •Known severe hearing loss or cognitive impairment
- •Known pregnancy, or positive pregnancy test, or breastfeeding
- •Patients known or suspected of not being able to comply with the study protocol due to alcoholism, noncompliance or any other cause
- •Life expectancy of less than 90 days due to co-morbid conditions
- •Concurrent participation in another research protocol for investigation of another experimental therapy
- •Severe, sustained hypertension (Systolic blood pressure> 180 mmHg or diastolic blood pressure> 110 mmHg).
- •Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs.
- •Any condition which, in the judgement of the investigator, might increase the risk to the patient.
研究组 & 干预措施
Intervention group
Subjects in the intervention group will receive remote ischemic conditioning and standard background medical treatment.
干预措施: Remote ischemic conditioning (Device)
Intervention group
Subjects in the intervention group will receive remote ischemic conditioning and standard background medical treatment.
干预措施: Standard medication therapy (Drug)
Sham group
Subjects in the placebo group will receive sham remote ischemic conditioning and standard background medical treatment alone.
干预措施: Sham remote ischemic conditioning (Device)
Sham group
Subjects in the placebo group will receive sham remote ischemic conditioning and standard background medical treatment alone.
干预措施: Standard medication therapy (Drug)
结局指标
主要结局
Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 90 Days
时间窗: 0-90 days.
The mRS ranges from 0 to 6, with higher scores indicating worse outcome. The primary outcome measure is the mRS score, dichotomized to define favorable functional outcome as mRS 0-2 at 90 days.
次要结局
- Number of Subjects With Serious Adverse Events Within 7 Days(7 days)
- Proportion of Patients With mRS Score 0-3 at 90 Days(90 days)
- Proportion of Patients With mRS Score 0-2 at 180 Days(180 days)
- Proportion of Patients With mRS Score 0-3 at 180 Days(180 days)
- Number of Subjects Experiencing Serious Adverse Events(90 days)
研究者
Ji Xunming,MD,PhD
Professor
Capital Medical University