iorEPOCIM-Stroke-Phase I

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000136
• Date of registration: 17/09/2012
• Primary sponsor: Center of Molecular Inmunology (CIM)
• Public title: iorEPOCIM-Stroke-Phase I
• Scientific title: Safety evaluation of human recombinant erythropoietin, iorEPOCIM, in stroke patients treatment.
• Date of first enrolment: 17/09/2012
• Target sample size: 20
• Recruitment status: Pending
• URL: http://registroclinico.sld.cu/trials/RPCEC00000136-En
• Study type: Interventional
• Study design: Randomization: N/A: single arm study. Blinding: Open. Placebo: Uncontrolled Assignment: Single Group Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Orestes Santos Morales
• Affiliation: Center of Molecular Inmunology (CIM)

• Name: Orestes Santos Morales
• Affiliation: CIM

Key inclusion & exclusion 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: 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.

Age minimum: 18 years
Age maximum: 80 years
Gender: Both

Health Condition(s) or Problem(s) studied

Stroke

Intervention(s)

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 first three days, Clopidogrel one tablet 75 mg each day during 3 months orally.

Primary Outcome(s)

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). Measuring time: at admittance and daily until the 5th day.

Secondary Outcome(s)

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.

Secondary ID(s)

M9/CIMAB/AEC-01

Source(s) of Monetary Support

Center of Molecular Inmunology (CIM)

Secondary Sponsor(s)

Not applicable