iorEPOCIM-Stroke-Phase I

Phase 1

• Conditions: Stroke

• Registration Number: RPCEC00000136
• Lead Sponsor: Center of Molecular Inmunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified