RPCEC00000185尚未招募1 期
Safety and efficacy of NeuroEPO in patients with stroke. Phase I-II
Center of Molecular Immunology, CIMAB0 个研究点开始时间: 2014年9月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 80 years（—）
- 性别
- All
入选标准
- •1.Both sex
- •2.Age between 18 and 80 years
- •3.NIHSS between 5 and 20
- •4.Score between 0 and 1 in the consciousness subscore of NIHSS
- •5.Upper airway permeable
- •6.Time between the onset of symptoms and treatment must be lower than 8 hours. Estimated from the information supplied by the patient or its relative:
- •-If onset during sleep, the time of going bed will be taken.
- •-If the patient can not communicate, the last time when the patient was seen well will be taken
- •7.Informed consent
排除标准
- •1.Presence of observable initial CT hyperdense lesion, whether by intraparenchymatous hemorrhage or cerebral infarction with hemorrhagic transformation
- •2.Isolated Neurological defects such as: ataxia, loss of sensation, dysarthria, or minimal muscle weakness.
- •3.Patients with symptoms or neurological signs that back to normal before the start of treatment.
- •4.Suspicion of inflammatory vascular diseases as a cause of the current Ischemic Brain Infarction (IBI) (lupus and other collagen diseases).
- •5.Trauma of skull or intracranial surgery recent (less than 4 weeks).
- •6.Known coagulation disorders.
- •7.Severe and uncontrolled arterial hypertension (diastolic >110 mm Hg or systolic >220) who does not descend after treatment.
- •8.Patients where proven coexistence of another disease or process that may lead to significant disability (cancer, septic embolism, endocarditis, malignant hypertension , Myeloproliferative disease, Creatinine >3 mg/dl, Hyperkalaemia > 5.0 mmol/L)
- •9.Patients with a history of hypersensitivity to the EPO-hr.
- •10.Pregnant or breastfeeding women.
- •11.Patients with a known allergy to any of the active substances that make up the product.
- •12.Patients presenting with nasal irritation (sneezing) or nasal discharge before starting treatment.
- •13.Patients who have asthma at the time of the initiation of treatment.
- •14.Patients who are receiving treatment with rTPA.
- •15.Signs of dysfunction of the brainstem.
- •16.Patients with severe liver disorders.
研究者
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