Safety evaluation of Recombinant Human Erythropoietin ior EPOCIM in the treatment of patient with Cerebral Infarction Acute.Study Stage I.

Center of Molecular Inmunology(CIM)0 个研究点目标入组 20 人开始时间: 2009年7月3日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Non-randomized controlled trial. Masking: Open. Control group: Uncontrolled. Assignment: Single group. Purpose: Treatment

•1.Consent for participation in the study of written patient or his legal representative. 2.Patients aged between 18 and 80 years. 3.Patients with a punctuation between 5 and 25 on the Ictus Scale of the Institute of Health Stroke of the United States.(National Institute of Health Stroke Scale-NIHSS). 4.Therapeutic window of less than or equal to 8 hours,from the time that symptoms appear,as calculated by the information provided by the patient or family.

•1.Presence of hyperdense lesion of blood observed on the initial CT,either intraparenchymal hemorrhage or Cerebral Infarction with haemorrhagic transformation. 2.Isolated neurological defects such as:ataxia,loss of sensation,muscle weakness or dysarthria minimum. 3.Patients with neurological symptoms or signs return to normal before the start of treatment. 4.Suspected inflammatory vascular diseases as a cause of the current ICI,lupus and other diseases of collagen. 5.Head trauma or intracranial surgery recently,less than 4 weeks. 6.Known bleeding disorder. 7.Severe arterial hypertension and non-controlled, higher systolic 220 or diastolic 110 mm Hg higher, which does not fall after treatment. 8.Patients with higher hematocrit of 47% or leukocytosis above 12 x 106 at debut. 9.Patients which demonstrated coexistence of another disease process or lead to significant disability, cancer,septic emboli,endocarditis,malignant hypertension,myeloproliferative disease,higher creatinine 3mg/dl,hyperkalaemia increased 5.0mmol/l. 10.Patients with a history of hypersensitivity to EPO-hr. 11.Pregnant or breast-feeding.

发起方

Center of Molecular Inmunology(CIM)