NCT00604630已完成2 期
German Multicenter EPO Stroke Trial (Phase II/III)
Max-Planck-Institute of Experimental Medicine9 个研究点 分布在 1 个国家目标入组 522 人开始时间: 2003年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 522
- 试验地点
- 9
- 主要终点
- Neurological/functional outcome as measured by the Barthel Index (BI)
研究概览
简要总结
The purpose of this randomized, double-blind, placebo-controlled multicenter study is to determine in a cohort of 506 patients with acute ischemic stroke in the middle cerebral artery territory, the effect of a three-day high-dose, intravenous erythropoietin treatment on functional outcome up to a follow-up of 90 days.
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
- •Ischemic stroke in the middle cerebral artery territory
- •Clearly defined time of onset
- •Confirmed by MRI (DWI, Flair)
- •NIH Stroke Scale ≥ 5
- •Age > 18 years
- •Treatment within 6h after onset of symptoms
- •Informed consent by patient, relatives or independent physician
- •Life expectancy > 90 days
排除标准
- •Coma or precoma (level of consciousness ≥ 2 in NIH Stroke Scale)
- •Previous stroke within the same territory
- •Intracranial or subarachnoidal hemorrhage
- •Traumatic brain injury or brain operation within the last 4 weeks
- •Neoplasia, septic embolism, infectious endocarditis
- •MRI contraindications
- •Renal failure (i.e. dependent on dialysis)
- •Known malignant/life-threatening disease
- •Known myeloproliferative disorder, polycythemia
- •Known allergy or antibodies against erythropoietin
- •Participation in other intervention trials
- •Pregnancy
研究组 & 干预措施
placebo
Placebo Comparator
50ml 0.9% NaCL
干预措施: 0.9% NaCl (Drug)
verum
Active Comparator
erythropoietin alfa 40,000 IU iv in 50ml 0.9% NaCl
干预措施: recombinant human erythropoietin alfa (Drug)
结局指标
主要结局
Neurological/functional outcome as measured by the Barthel Index (BI)
时间窗: day 90
次要结局
- Modified Rankin Scale (mRS) responder(day 90)
- Barthel Index (BI)(day 30)
- mRS(day30, day 90)
- NIH Stroke Scale(day 1, 3, 7, 30, 90)
- Proportion of subjects with minimal disability (mRS 0-1)(day 30, day 90)
- All-cause mortality(day 90)
- Mortality directly related to stroke(day 90)
- Proportion of subjects with BI >= 95(day 30, day 90)
- Proportion of subjects with BI=100(day 30, day 90)
- Proportion of subjects with neurological recovery(day 3, 7, 30, 90)
- Distribution of mRS scores(day 30, day 90)
- Distribution of BI scores(day 30, day 90)
- Distribution of NIH Stroke Scale scores(day 30, day 90)
- Serum level of glial damage markers S100B and GFAP(day 1, 2, 3, 4, 7)
- Lesion size (MRI DWI, flair)(day 1, day 7)
- Overall survival(day 90)
- Late recovery index (BI day 90 versus BI day 30)(day 30 to day 90)
研究者
研究点 (9)
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