Acute Cerebral Ischemic Stroke.
Conditions
Interventions
ior EPOCIM: 3.3 x 104 IU in the form of intravenous infusion and hydration with saline solution at 0.9% a rate of between 1500 and 2000 mL daily for three consecutive days and Acetylsalicylic acid (A
Sponsors
Center of Molecular Inmunology(CIM)
No proceed
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Consent for participation in the study of written patient or his legal representative. 2.Patients aged between 18 and 80 years. 3.Patients with a punctuation between 5 and 25 on the Ictus Scale of the Institute of Health Stroke of the United States.(National Institute of Health Stroke Scale-NIHSS). 4.Therapeutic window of less than or equal to 8 hours,from the time that symptoms appear,as calculated by the information provided by the patient or family.
Exclusion criteria
Exclusion criteria: 1.Presence of hyperdense lesion of blood observed on the initial CT,either intraparenchymal hemorrhage or Cerebral Infarction with haemorrhagic transformation. 2.Isolated neurological defects such as:ataxia,loss of sensation,muscle weakness or dysarthria minimum. 3.Patients with neurological symptoms or signs return to normal before the start of treatment. 4.Suspected inflammatory vascular diseases as a cause of the current ICI,lupus and other diseases of collagen. 5.Head trauma or intracranial surgery recently,less than 4 weeks. 6.Known bleeding disorder. 7.Severe arterial hypertension and non-controlled, higher systolic 220 or diastolic 110 mm Hg higher, which does not fall after treatment. 8.Patients with higher hematocrit of 47% or leukocytosis above 12 x 106 at debut. 9.Patients which demonstrated coexistence of another disease process or lead to significant disability, cancer,septic emboli,endocarditis,malignant hypertension,myeloproliferative disease,higher creatinine 3mg/dl,hyperkalaemia increased 5.0mmol/l. 10.Patients with a history of hypersensitivity to EPO-hr. 11.Pregnant or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event type, event name,measurement time after the first infusion and up to 3 months. Duration of adverse events, measurement time: from the first infusion and up to 3 months. Severity of adverse events, serious or not, measurement time: from the first infusion and up to 3 months. Intensity of adverse events, mild, moderate, severe, measurement time: after the first infusion and up to 3 months. Attitude to the drug: change, change in dose or temporary interruption of the final treatment, measurement time: after the first infusion and up to 3 months. Result: Recovered, Improved, persists or left Aftermath, measurement time: after the first infusion and up to 3 months. Causal relationship, very likely, likely, possible, unlikely, not related or not assessable), measurement time: after the first infusion and up to 3 months. Treatment, measurement time: from the first infusion and up to 3 months. Blood pressure values, T/A in mm/Hg, every 4 hours during the first 3 days and every 8 hours until discharge. Body temperature in degree celcius every 4 hours during the first 3 days and every 8 hours until discharge. Hemoglobin (g/l), hematocrit (%), measurement time: at admission and daily until the 5th day. | — |
Secondary
| Measure | Time frame |
|---|---|
| Neurological status of the patient, between 0 and 4 points, measurement time: 7 days, 3 months of treatment. Functional status of the patient assessments at intervals of 5 points between 0 and 15, measurement time: 7 days, 3 months of treatment. | — |
Countries
Cuba
Contacts
Public ContactMD.Patricia Piedra
CIMAB S.A
Outcome results
None listed