Safey and Efficacy of Remote Ischemic Conditioning in Patient With Spontaneous Intracerebral Hemorrhage
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety]
研究概览
简要总结
Spontaneous intracerebral hemorrhage (ICH) results from the rupture of small vessels damaged by chronic hypertension, amyloid angiopathy or other disease. Hematoma volume has been demonstrated to be strongly correlated with the severity of white matter injury and conditions in ICH patients. In the past decades, surgical clot evacuation and stereotactic or endoscopic clot aspiration with thrombolytic drugs have been investigated for the treatment of ICH, however, none of them have been demonstrated to be effective. As such, medical management remains the standard of care for most patients with ICH, leading to ICH as the least treatable form of stroke.
Remote ischemic conditioning (RIC) 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. Therefore, the investigators plan to undertake this study to evaluate the safety of RIC in patients with ICH, and planned for future study to determine if treatment with RIC can improve the outcome of patients with ICH.
In this study, our main objectives are: 1) to evaluated the safety of RIC, by determining the treatment related adverse events, in patients with ICH; and 2) to determine the preliminary effects of RIC on hematoma absorption and cerebral edema.
The investigators hypothesize that RIC is well-tolerated and has minimal serious adverse effects in patients with ICH; and 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
- 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
- •Age≥18 and ≤
- •The diagnosis of ICH is confirmed by brain CT scan.
- •Hematoma volume of 10 to 30 ml.
- •Glasgow Coma Score (GCS)>
- •Starting RIC treatment between 24 and 48 hours of ictus.
- •Signed and dated informed consented is obtained.
排除标准
- •Patients with suspected secondary ICH related to tumor, coagulopathy, ruptured aneurysm or arteriovenous malformation, or venous sinus thrombosis.
- •ICH concomitant with subarachnoid hemorrhage or intraventricular hemorrhage. Planned surgical evacuation of hematoma prior to RIC.
- •Evidence of significant shift of midline brain structure (> 10 mm) or herniation on brain imaging.
- •Known pregnancy (or positive pregnancy test), or breast-feeding.
- •Concurrent participation in another research protocol for investigation of another experimental therapy.
- •Patients with a pre-existing neurological deficits (modified Ranks scale score >1) or psychiatric disease that would confound the neurological or functional evaluations.
- •Life expectancy of less than 90 days due to co-morbid conditions.
- •Severe hepatic and renal dysfunction.
- •Severe, sustained hypertension (SBP > 180 mmHg or DBP > 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 judgment of the investigator, might increase the risk to the patient.
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety]
时间窗: 7 days.
次要结局
未报告次要终点
研究者
Ji Xunming,MD,PhD
Professor
Xuanwu Hospital, Beijing