NCT02603406已完成2 期
Neovascularization Induced by Mechanical Barrier disrUption and Systemic Erythropoietin in Patients With Cerebral Perfusion Deficits (NIMBUS Trial)
Ajou University School of Medicine0 个研究点目标入组 44 人开始时间: 2016年7月15日最近更新:
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
- 44
- 主要终点
- Successful new vascularization of internal-to-external cerebral collateral flow
研究概览
简要总结
Neovascularization Induced by Mechanical Barrier disrUption and Systemic erythropoietin in patients with cerebral perfusion deficits (NIMBUS trial)
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
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 20~85
- •Acute period (ischemic stroke confirmation on DWI or TIA within 14 days after symptom onset)
- •Below 20 point of initial NIHSS score within 14 days after stroke onset and enrolment.
- •Confirmation of atherosclerotic or steno-occlusive stroke mechanism (proximal cerebral arteries) on CTA or MRA .
- •At least hemodynamically, perfusion status of a candidate is stage II or III (decrease of regional Cerebral blood flow on CBF map), moyamoya disease
- •If female then not of childbearing potential
- •Informed consent
排除标准
- •Primary intracerebral haemorrhage (ICH), or parenchymal haemorrhagic transformation of infarction (type PHI or PHII as defined in ECASS), subarachnoid haemorrhage (SAH), arterio-venous malformation (AVM), cerebral aneurysm, or cerebral neoplasm
- •Treated with a thrombolytic <24 hours (if >24 hours and excluded ICH then eligible)
- •Score >=1 on the NIHSS item 1a
- •Pre-stroke mRS score <2
- •Uncontrolled hypertension(irregularity systollic BP > 150mmHg
- •Previous treatment with erythropoietin
- •At screening: Hemoglobin >14 g/dl, prolonged PT or PTT, serum Cr >2.0 ,mg/dl, BUN >40, thrombocytopenia or neutropenia as defined by the lower limit of normal for the platelet count or white blood cell count, respectively (absolute neutrophil count of > 1800/mm3 required for participation), or > 2 times of normal on liver function tests (SGOT, SGPT, total bilirubin)
研究组 & 干预措施
Group A
Experimental
mechanical barrier disruption procedure + hrEPO manufactured by Dong-A pharmaceutics Multiple burrholes with local anesthesia after medication Drug: Erythropoietin 33,000u daily for 3 day via intravenous
干预措施: erythropoietin (Drug)
结局指标
主要结局
Successful new vascularization of internal-to-external cerebral collateral flow
时间窗: 6 months
transdural neovascularization: absent vs. present) from 6- vessel angiography
次要结局
- Early Neurological Deterioration (END) during admission(14 days)
- Adverse events during the study period(up to 6 months)
研究者
Ji Man Hong
Associate professor
Ajou University School of Medicine
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