STROKE Ischemic stroke
Conditions
Interventions
Stage I
Group A (Experimental)-NeuroEpo 1mg (13 patients): It will receive 1.0 mg of NeuroEPO by nasal route every 8 hours for 3 days. From the 4th day and up to the 7th 1.0 mg 1 time a day
from the 8th day until the month 3, 0.5mg 3 times a week.
Group B (Experimental)-NeuroEpo 0.5mg (13 patients): It will receive 0.5 mg of NeuroEPO by nasal route every 8 hours for 3 days. From the 4th
from the 8th day until the month 3, 0.5mg 3 times a week.
Group C (Control)-Placebo (13 patients): It will be divided into 2 parts. One part (7 patients) will receive 1.0 mg of Placebo every 8 hours f
Erythropoietin
Administration, Intranasal
Placebos
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Serious adverse events with definite causal association, very probable or probable with the administration of the product. Measurement time: in each product administration, 3, 7 days, 1, 3, 6 months. 2. Degree of ICTUS (NIHHS scale). Measurement time: at baseline, 7 days, 1, 3 and 6 months. 3. Functional statu (Barthel index). Measurement time: 3 and 6 months. 4. Degree of disability (Rankin scale). Measurement time: 3 and 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Security variables: 1. Adverse events-AD (Gravity of the AD (severe or not), Type of AD (according to categories of Regulation 45 of 2007 of the CECMED), Intensity of the AD (mild, moderate, severe), Causality of the AD (very probable, probable, possible, improbable, unrelated or non-evaluable), Attitude towards the drug (No change, Dose reduction, Temporary interruption of treatment, Definitive interruption of treatment), Result (Reversible effect, Irreversible effect, Death, Loss of follow-up of the patient)). Measurement time: 3, 7 days, 1, 3 and 6 months and in each administration of the product 2. Blood pressure (mm / hg). Measurement time: The 1st day every 4 hrs. From day 2 to discharge (day 7) cda 8 hrs, evaluation to the month, 3 and 6 months and in each administration of the product 3. Laboratory tests (Hemoglobin (normal, abnormal), Hematocrit (normal, abnormal), Normal platelet count, abnormal), WBC count (normal, abnormal), Prothrombin and thromboplastin (normal, abnormal),TGO (normal, abnormal), TGP (normal, abnormal), Creatinine (normal, abnormal), uric acid (normal, abnormal), sodium (normal, abnormal), potassium (normal, abnormal)). Measurement time: On admission, day 4, month and 3 months Related to efficiency 4. Post-stroke depression (Geriatric Depression Scale. The presence of depression will be defined when the score of the scale is greater than or equal to 10). Measurement time: 3 and 6 months. 5. Post-stroke quality of life (Scale of Quality of Life for Stroke). Measurement time: 3 and 6 months. 6. Cognitive impairment post-stroke (MMSE). Measurement time: 3 and 6 months. | — |
Countries
Cuba
Contacts
Public ContactLeslie Perez Ruiz
Center of Molecular Immunology (CIM)
Outcome results
None listed