Stroke
Conditions
Interventions
ior®EPOCIM 3,3 x 104 UI/d x 3days. To dilute in 50 mL of Saline Solution 0.9%. To administer in form of slow IV infusion (30 minutes), saline solution 0.9% between 1500 and 2000mL each day during the
Sponsors
Center of Molecular Inmunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Type of Adverse Event (Name of the adverse event). Measuring time: day 3, day 7, 1 month, 3 months. Duration ( Difference between the beginning and the end of the adverse effect). Measuring time: day 3, day 7, 1 month, 3 months. Intensity (Mild, moderate, severe). Measuring time: day 3, day 7, 1 month, 3 months. Severity (SerioUs/No serious). Measuring time: day 3, day 7, 1 month, 3 months. Attitude toward the drug (No change, dose modification, temporary interruption, definitive interruption). Measuring time: day 3, day 7, 1 month, 3 months. Consequence (Recovered, improved,persistent, sequelae). Measuring time: day 3, day 7, 1 month, 3 months. Causality (Very probable, probable, posible, not probable, not related, not evaluable). Measuring time: day 3, day 7, 1 month, 3 months. Treatment (any treatment received during the study different to the intervention drugs). Measuring time: day 3, day 7, 1 month, 3 months. Blood pressure (mm Hg). Measuring time: every 4 hours during the first 3 days and every 8 hours until discharge. Temperature (centigrades degrees). Measuring time: every 4 hours during the first 3 days and every 8 hours until discharge. Glicaemia (mmol/L). Measuring time: at admittance and daily until the 5th day. Hemoglobin (g/L). Measuring time: at admittance and daily until the 5th day. Hematocrit (cu). Measuring time: at admittance and daily until the 5th day. Leukocites count (10 9/L). Measuring time: at admittance and daily until the 5th day. Uric acid (mmol/L). Measuring time: at admittance and daily until the 5th day. Creatinin (µmol/L). Measuring time: at admittance and daily until the 5th day. Potassium (µmol/L). Measuring time: at admittance and daily until the 5th day. Sodium (µmol/L). Measuring time: at admittance and daily until the 5th day. Platelets count (10 9/L). Measuring time: at admittance and daily until the 5th day. Prothrombin partial time (sec). Measuring time: at admittance and daily until the 5th day. Thrombine time (sec). Measu | — |
Secondary
| Measure | Time frame |
|---|---|
| National Institute of Health Stroke Scale (NIHSS). Measuring time: at admittance, 3 and 7 days, 1 month and 3 months. Daily life activities (Barthel Index). Measuring time: 7days, 1 and 3 months. | — |
Countries
Cuba
Contacts
Public ContactOrestes Santos Morales
CIM
Outcome results
None listed