Efficacy and Safety of Young Health Plasma on Acute Stroke
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 78
- 主要终点
- Changes in modified Barthel Index
研究概览
简要总结
Stroke is one of the main severe disease of public health importance. Recent studies showed that old age is one of the most important factors in influencing the outcome of patients with acute stroke, and the young plasma can reverse age-related brain impairments in mice. Therefore, this pilot study aims to investigate whether young plasma is effective in alleviating brain injury and neurologic deficits induced by acute stroke in patients.
详细描述
This study will enroll 78 stroke patients who have been diagnosed with stroke and meet the inclusion criteria.
After successfully meeting initial screening criteria, investigators will contact the family, explain the study, and send a consent form for their review.
After that, patients will be given 2 unit/day young health plasma (young plasma exchange) over a course of 3 consecutive days, then investigators will make a neurofunctional assessment before and 7 days, 30 days and 90 days after young health plasma treatment. And Magnetic Resonance of the brain before, 7 days, 14 days and 90 days after young health plasma treatment.
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
- None
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65-80 years
- •Clinical presentation of spontaneous intracerebral hemorrhage/ischemic stroke
- •CT/MRI/MRA scan compatible with spontaneous intracerebral hemorrhage/ ischemic stroke
- •Time to young plasma treatment < 72 h from symptom onset
- •Glasgow Coma Score > 6 on initial presentation or improvement to a Glasgow Coma Score > 6 within the time frame for enrollment
- •The first-ever primary supratentorial intracerebral basal ganglia hemorrhage 5-30ml
- •Signed and dated informed consent is obtained
- •TOAST: Large-artery atherosclerosis
排除标准
- •Patients who will undergo surgical evacuation of intracerebral hemorrhage/ischemic stroke
- •Inability to undergo neuroimaging with Magnetic Resonance
- •Glasgow Coma Score < 6
- •Significant past history of disability, modified Rankin Scale（mRS）≥1
- •Primary intraventricular hemorrhage ICH due to coagulopathy (PT > 15 s or International Normalized Ratio > 1.3, Partial Thromboplastin Time > 36) or trauma
- •Thrombocytopenia: platelet count <100 000
- •Clinically significant hepatic disease as demonstrated by history, clinical exam (ascites, varices), or laboratory findings (LFTs >2x normal, coagulopathy as described)
- •Comorbid conditions likely to complicate therapy including but not limited to the following: a history of New York Heart Association class II, III, or IV Congestive Heart Failure; end-stage acquired immune deficiency syndrome
- •Known pregnancy, or positive pregnancy test, or breast feeding
- •Malignancy (history of or active)
- •Bradyarrhythmia and Atrioventricular Block
- •Concomitant use with antineoplastic,immunosuppressive or immune modulating therapies
- •Macular Edema
- •Life expectancy of less than 90 days due to comorbid conditions
- •Occurrences of secondary intracerebral hemorrhage/ischemic stroke
- •Patients known or suspected of not being able to comply with the study protocol due to alcoholism, drug dependency, noncompliance, living in another state or any other cause
研究组 & 干预措施
young Fresh Frozen Plasma
- Drug: young plasma will be administered as 2 unit /day over a course of 3 consecutive days after stroke onset.
- Drug: young plasma exchange over a course of 3 consecutive days after stroke onset.
干预措施: young Fresh Frozen Plasma (Drug)
old Fresh Frozen Plasma
- Old plasma will be administered as 2 unit /day over a course of 3 consecutive days after stroke onset.
- Old plasma exchange over a course of 3 consecutive days after stroke onset.
- Patients will receive usual care and drug use in hospital.
干预措施: old Fresh Frozen Plasma (Drug)
结局指标
主要结局
Changes in modified Barthel Index
时间窗: up to 90 days
describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days
Changes in Glasgow coma scale
时间窗: up to 90 days
describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days
Changes in National Institutes of Health Stroke Scale (NIHSS)
时间窗: up to 90 days
describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days
Changes in modified Rankin Scale
时间窗: up to 90 days
describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days
次要结局
- Change in peripheral edema volume(At baseline, 7 days, 14 days and 30 days after the onset)
- Changes in hematoma volume(At baseline, 7 days, 14 days and 30 days after the onset)
研究者
Xiao-Yi Xiong
Medical Doctor
Xinqiao Hospital of Chongqing