Safety and Evidence of the Effect of NeuroEPO in patients with Acute CerebRal Infarction. Ph I-II. - SErONICA

Center of Molecular Immunology (CIM)0 个研究点目标入组 130 人开始时间: 2018年8月2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: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment

•1- Patients with ages equal to or greater than 19 years.
•2- Patients with a score between 6 and 20 on the neurological scale NIHSS. They must have a score of 0 or 1 in the level of awareness section of said scale.
•3- Have permeable airways.
•4- Time elapsed between the onset of symptoms and the start of treatment = 24 hours. Calculated from the information provided by the patient or family member:
•- If the debut occurs during sleep, it will be taken the time you went to sleep.
•- If you can not communicate, by altering the language or speech, you will take the last hour when you saw it well.
•5- Patients and / or relative or legal tutor who grant their consent to participate in the study.

•1- Isolated neurological defects such as: ataxia, loss of sensitivity or minimal muscle weakness.
•2-Patients with neurological symptoms or signs that return to normal before the start of treatment.
•3-Suspected vascular inflammatory diseases as a cause of current ICTUS (lupus and other collagen diseases).
•4-Skull trauma or recent intracranial surgery (less than 4 weeks).
•5-Known coagulation disorders.
•6-Severe and uncontrolled arterial hypertension (systolic> 220 or diastolic> 110 mm Hg) that does not descend after treatment.
•7-Patients where coexistence of another disease or process leading to significant disability is demonstrated (cancer, septic embolism, endocarditis, malignant hypertension, myeloproliferative disease, creatinine> 3 mg / dl, hyperkalemia> 5.0 mmol / L).
•8-Patients with a history of hypersensitivity to EPO-hr.
•9-Women who are pregnant or breast-feeding.
•10-Patients with a known allergy to any of the active substances that make up the product.
•11-Patients who present nasal irritation (sneezing) or nasal discharge before starting treatment.
•12-Patients who present asthma attacks at the time of treatment initiation.
•13-Patients who are receiving rTPA treatment.
•14-Signs of brain stem dysfunction.
•15-Patients with severe liver disorders

发起方

Center of Molecular Immunology (CIM)