Acute cerebral infarction of ischemic etiology
Conditions
Interventions
Group I (experimental): Serendictus (75 µg of recombinant epidermal growth factor [EGF] combined with 5.0 mg of the growth hormone releasing peptide [GHRP-6]) + conventional treatment. Serendictus wil
Epidermal Growth Factor
Peptides
Administration, Intravenous
Serendictus,
Recombinant Epidermal Growth Factor,
GHRP-6
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), in Havana
Eligibility
Sex/Gender
All
Age
19 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Compliance with the diagnostic criteria (patients of both sexes, with a focal neurological defect caused by disturbances of the circulatory supply to a specific brain area, confirmed by computerized axial tomography images). 2. Age between 19 and 80 years, both inclusive. 3. Time between the onset of symptoms and the beginning of the administration of Serendictus less than 12 hours. 4. Voluntariness of the patient (or family member) through the granting of informed consent (oral).
Exclusion criteria
Exclusion criteria: 1. Coma state (Glasgow scale less than 8). 2. Score on the NIHSS scale 20. 3. When the neurological defect can be explained by another entity different from the acute cerebral infarction. 4. Patients with neurological symptoms or signs that return to normal before the start of treatment. 5. Severe and uncontrolled arterial hypertension (systolic >200 mmHg or diastolic> 120 mmHg) that does not descend after treatment. 6. Arterial hypotension (systolic <95 mmHg) that does not respond to the usual treatment. 7. How to install the clinical picture with seizures. 8. Patients with basic neurological alterations that could interfere with the functional evaluation process during the course of the study. 9. Patients diagnosed with malignant neoplasms. 10. Pregnancy or lactation at the time of inclusion in the study (referred by the patient or family member). 11. Obvious mental inability to issue consent and act accordingly with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neurological status-disability (It will be evaluated according to the Rankin scale in 0: No symptoms; 1: No significant involvement despite the symptoms, possibility of performing all the activities of daily life; 2: Light disability, can not perform all the activities of daily life, but is able to attend to their bodily needs without help; 3: Moderate disability, requiring some help to satisfy their bodily needs but able to walk without help: 4: Moderately severe disability, inability to wander without help and to attend to their needs. bodily needs without help, 5: severe disability, bedridden, incontinent and with constant need for nursing care and attention). Measurement time: at discharge, and in months 1, 3, 6 and 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival (alive, dead). Measurement time: at hospital discharge and during follow-up in months 1, 3, 6 and 12. Level of neurological deficit (It will be measured through the scale of NIHSS (National Institute of Heath Stroke Scale): Measurement time: to inclusion and hospital discharge. Ability to perform daily activities (It will be assessed through the Barthel index that measures the degree of dependence on the basic activities of daily life and a value = 85 will be considered favorable, independence with minimal help). Measurement time: at 3, 6 and 12 months. Infarct volume (by Computerized Axial Tomography). Measurement time: to the inclusion, to the 4th, to the 8th and to the 30 days of the beginning of the treatment. Adverse clinical events (AE). They will be measured as: -AE occurrence (Yes, No), -AE description (event name), -AE intensity (mild, moderate, severe), -Relation of causality (unrelated, doubtful, possible, probable, definitive), -Measures taken (None, Administration of any pharmacological therapy, Addition of a non-pharmacological therapy, Exit of the study, Hospitalization / prolongation of the hospitalization), -Result (Completely resolved, Resolved with sequelae, Conditions in improvement, Condition present and unchanged, Worsening, Death caused by this event). Measurement time: daily in Week 1 and in months 1, 3, 6 and 12. Laboratory (numerical values ??of hemochemical tests: blood count, hematocrit, differential leukogram, platelet count, coagulogram, ALAT, ASAT, glycemia, creatinine, urea, uric acid, alkaline phosphatase, total proteins, albumin, bilirubin and cholesterol). Measurement time: at the beginning, on the 8th day (at discharge) and on the evaluations corresponding to months 1 and 6. Efficiency of Serendictus in the treatment of acute cerebral infarction of ischemic etiology, through the evaluation of incremental cost effectiveness (defined as the difference between the costs of the treatments that are compared on the difference b | — |
Countries
Cuba
Contacts
Public ContactFrancisco Hernandez Bernal
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed