Safety evaluation of human recombinant erythropoietin, iorEPOCIM, in stroke patients treatment.

Center of Molecular Inmunology (CIM)0 个研究点目标入组 20 人开始时间: 2012年9月17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: N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Treatment

•1. Written consent. 2. Age between 18 and 80 years. 3. NIHSS between 5 and 25. 4. Therapeutic window lower or equal to 8 hours according the information supported by the patient or the relative.

•1. Hiperdense lesion of blood at the initial Axial Computarized Tomography, due to intraparenquimatous hemorrage or hemorragic transformation of stroke. 2. Neurologic deficit like: ataxia, loss of sensibility, dysartria or minimal muscle weakness. 3. Neurologic symptoms or signs that return to normality before treatment start. 4. Suspect of inflammatory vascular diseases (lupus and other colagenous diseases). 5. Head trauma or recent intracraneal surgery (less than 4 weeks). 6. Known coagulation disorder. 7. Serious high blood pressure not controlled (systolic > 220 or diastolic >110 mm Hg) that dont improve with treatment. 8. Hematocrit levels > 42% or leukocytes > 12 x 10 6. 9. Other concomittant diseases or process producing important disability (cancer, septic embolisms, endocarditis, malign hipertension, mieloproliferative disease, creatinin >3 mg/dl, potassium >5.0 mmol/L. 10. History of hypersensitivity to hr-EPO. 11. Pregancy or breast feeding periods.

发起方

Center of Molecular Inmunology (CIM)